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Which Trees Make a Forest Work? Smithsonian Scientists Are Planting Over 33,000 To Find Out
WASHINGTON, April 15 -- The Smithsonian Institution Environmental Research Center issued the following news release:* * *
Which Trees Make a Forest Work? Smithsonian Scientists Are Planting Over 33,000 To Find Out
Functional Forests Project Will Root Out Clues to "Smart Reforestation" by Planting Trees in Five-Species Combos
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To grow a successful forest, planting trees is not enough. A new forest needs the right trees to withstand future threats and meet the needs of both wildlife and people. This spring, scientists and volunteers are planting a new type of forest at the Smithsonian Environmental ... Show Full Article WASHINGTON, April 15 -- The Smithsonian Institution Environmental Research Center issued the following news release: * * * Which Trees Make a Forest Work? Smithsonian Scientists Are Planting Over 33,000 To Find Out Functional Forests Project Will Root Out Clues to "Smart Reforestation" by Planting Trees in Five-Species Combos * To grow a successful forest, planting trees is not enough. A new forest needs the right trees to withstand future threats and meet the needs of both wildlife and people. This spring, scientists and volunteers are planting a new type of forest at the Smithsonian EnvironmentalResearch Center (SERC). The Functional Forests project will test different combinations of tree species to uncover which ones set up a forest for success.
Worldwide, forest restorations are one of the most popular ways to combat environmental degradation and mitigate climate change. They are also invaluable resources for food, timber and habitat for wildlife.
"Forests are the lungs and bones of our planet," said SERC Director Monty Graham. "But there's no such thing as a one-size-fits-all forest. We need big data to find out which types of forests have the best shot at success, and where. That's why large and long-term experiments like this are so critical."
The vast majority of forest restorations contain just one tree species--leaving them vulnerable to pests like the emerald ash borer or the fungal disease anthracnose, which has killed or disfigured millions of dogwood trees since the 1980s. Tree plantations, harvested for timber, are also dominated by long stretches of a single species.
"It's all about risk management," said John Parker, SERC senior scientist co-leading the forest restoration. "Plant the wrong species and you could lose it all. But if you plant a mixture of species, it lessens that risk in the same way that a mutual fund is less risky than a single stock. This is why high biodiversity is sometimes called a 'portfolio effect.'"
Parker is one of two SERC scientists leading the 33,500-tree forest experiment. The other project lead is Justin Nowakowski, a senior scientist who specializes in conservation science. Their team is investigating how to design forests that can simultaneously provide different functions, including food, wildlife habitat, timber, resistance to deer browsing and climate resilience.
"Looking beyond the number of species planted, we need to understand how different mixtures of species and traits perform together," Nowakowski said. "Tree planting organizations want to know what palettes of species are going to survive well in future climate conditions while maximizing the multiple benefits trees can provide."
The forest will take root on SERC's campus in Edgewater, Maryland, on the western shore of Chesapeake Bay. The entire project will contain 20 species, ranging from towering oaks and sycamores to low-lying shrubs like beautyberry. But rather than mixing them all together, the scientists are planting a mosaic of "mini-forests." The experiment will contain 194 plots, each containing either one tree species or a combination of five species, plus six plots left to grow naturally for comparison. Each five-species blend was chosen to test the plot's ability to produce food, grow timber, attract wildlife, resist deer browsing or withstand climate change.
The team will also test different densities, with some trees spaced 2.5 meters (about 8 feet) apart and others spaced 1 meter (about 3 feet) apart, to see if the tighter spaces can suppress weeds and invasive species. Some of the plots will have deer fences, so the team can test which trees are least likely to get eaten by a hungry herbivore.
"We've seen how hungry deer can set a young forest back years," said Jamie Pullen, head technician in Parker's lab. "The trees they prefer, maples for example, get browsed so often that some are still stuck at knee height more than a decade later. That kind of pressure doesn't just slow a planting, it changes what the forest will look like decades from now. With this project's exclosures, we will finally be able to measure how much early protection can shift the long term course of a restoration."
Functional Forests is not the first massive forest experiment on SERC's campus. In 2013, Parker's lab planted BiodiversiTREE, a nearly 18,000-tree forest experiment he manages with Pullen that is still going on today. It has a similar design: multiple mini-forests with one, four or 12 species.
BiodiversiTREE was created to answer a different question: Does diversity in a forest matter at all? A decade later, the experiment offered a resounding yes. The more diverse forest plots grew larger, stored more carbon and were less likely to boom or bust--an issue that plagued many single-species plots. They also sheltered more wildlife, especially birds, insects and spiders.
"These diverse plots often have a more complex structure, providing more habitat and resources for different species to use," said Shelley Bennett, a technician in Nowakowski's lab who has also worked in BiodiversiTREE. "In addition, the layering of tree canopies creates shaded, cool understories that forest animals rely on."
Functional Forests takes the question one step further. It asks which specific trees help a forest meet different needs.
"BiodiversiTREE taught us that biodiversity strengthens forests," Parker said. "Functional Forests is about using that knowledge to build the forests we need for the future."
Researchers and volunteers will plant trees throughout April. To learn more about the project, interview the team or visit the site, contact Kristen Goodhue at GoodhueK@si.edu.
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Original text here: https://www.si.edu/newsdesk/releases/which-trees-make-forest-work-smithsonian-scientists-are-planting-over-33000-find
State Dept.: Sanctioning Senior Operatives of Cartel Del Noreste
WASHINGTON, April 15 -- The U.S. State Department issued the following statement on April 14, 2026, by Principal Deputy Spokesperson Tommy Pigott:* * *
Sanctioning Senior Operatives of Cartel del Noreste
Today, the Trump Administration is imposing sanctions on Cartel del Noreste (CDN)-linked casinos and senior operatives who enable the cartel's money laundering, drug trafficking, and human smuggling activities along key border corridors, including Nuevo Laredo. These actions target the financial and logistical networks that sustain one of Mexico's most violent criminal organizations, which ... Show Full Article WASHINGTON, April 15 -- The U.S. State Department issued the following statement on April 14, 2026, by Principal Deputy Spokesperson Tommy Pigott: * * * Sanctioning Senior Operatives of Cartel del Noreste Today, the Trump Administration is imposing sanctions on Cartel del Noreste (CDN)-linked casinos and senior operatives who enable the cartel's money laundering, drug trafficking, and human smuggling activities along key border corridors, including Nuevo Laredo. These actions target the financial and logistical networks that sustain one of Mexico's most violent criminal organizations, whichthe United States has designated as both a Foreign Terrorist Organization (FTO) and a Specially Designated Global Terrorist.
Cartel del Noreste's violence and intimidation, including its March 2022 attack on the U.S. Consulate in Nuevo Laredo, threaten U.S. personnel, undermine Mexican sovereignty, and destabilize communities on both sides of the border. By degrading CDN's revenue streams and safe havens, the United States is acting to protect lawful cross-border commerce, safeguard American border communities, stop the trafficking of fentanyl and other illicit drugs killing Americans, and strengthen our shared efforts with Mexico to degrade and dismantle narco-terrorist organizations.
Today's action continues to deliver on President Trump's promise to the American people to protect our homeland, counter drug trafficking, dismantle human smuggling networks, and confront the corruption and violence that these foreign organizations fuel throughout our region. These steps underscore the Trump Administration's commitment to use all tools available to disrupt and dismantle narco-terrorist groups that endanger the United States and our partners.
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The action was taken pursuant to Executive Order (E.O.) 14059, which targets the international proliferation of illicit drugs and their means of production, and pursuant to E.O. 13224, as amended, which targets terrorists and their supporters. This is the third action targeting CDN's leadership and affiliates during the Trump Administration. For more information about today's designations, please see Treasury's press release (https://home.treasury.gov/news/press-releases/sb0440).
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Original text here: https://www.state.gov/releases/office-of-the-spokesperson/2026/04/sanctioning-senior-operatives-of-cartel-del-noreste/
Lobbying Firm and Its Owner Ordered to Pay $400,000 for Fraudulently Obtained Paycheck Protection Program Loans
ALEXANDRIA, Virginia, April 15 -- The office of the U.S. Attorney for the Eastern District of Virginia posted the following news release on April 14, 2026:* * *
Lobbying firm and its owner ordered to pay $400,000 for fraudulently obtained Paycheck Protection Program loans
The U.S. District Court for the Eastern District of Virginia ordered Iseman & Associates LLC, a lobbying firm located in West Palm Beach, Florida, and its owner Vicki Iseman, to pay $408,730.44 after finding that they submitted fraudulent applications to obtain federally guaranteed loans through the Paycheck Protection Program ... Show Full Article ALEXANDRIA, Virginia, April 15 -- The office of the U.S. Attorney for the Eastern District of Virginia posted the following news release on April 14, 2026: * * * Lobbying firm and its owner ordered to pay $400,000 for fraudulently obtained Paycheck Protection Program loans The U.S. District Court for the Eastern District of Virginia ordered Iseman & Associates LLC, a lobbying firm located in West Palm Beach, Florida, and its owner Vicki Iseman, to pay $408,730.44 after finding that they submitted fraudulent applications to obtain federally guaranteed loans through the Paycheck Protection Program(PPP).
In March 2025, the United States filed a Complaint against Iseman & Associates and Iseman alleging that they had violated the False Claims Act (FCA) and Financial Institutions Reform Recovery and Enforcement Act (FIRREA) by submitting false documents and falsely certifying eligibility for two PPP loans. Businesses primarily engaged in lobbying or political activities were categorically ineligible to obtain PPP loans. According to the government's complaint, Iseman & Associates and Iseman had submitted falsified tax documents and made false certifications as part of their PPP loan applications.
The District Court found that the United States had shown it was entitled to judgment on the FCA and FIRREA claims asserted against the defendants and, accordingly, awarded the United States summary judgment, and entered judgment that included treble damages and penalties under the FCA.
The outcome in this case was the result of a coordinated effort between the U.S. Attorney's Office for the Eastern District of Virginia, the U.S. Small Business Administration's Office of General Counsel, Litigation Unit, and the U.S. Small Business Administration, Office of Inspector General. The matter was prosecuted by Assistant U.S. Attorney John E. Beerbower, assisted by Forensic Auditor Peter Melaragni.
On April 7, the Department of Justice announced the creation of the National Fraud Enforcement Division. The core mission of the Fraud Division is to zealously investigate and prosecute those who steal or fraudulently misuse taxpayer dollars. Department of Justice efforts to combat fraud support President Trump's Task Force to Eliminate Fraud, a whole-of-government effort chaired by Vice President J.D. Vance to eliminate fraud, waste, and abuse within Federal benefit programs.
A copy of this press release may be found on the website of the U.S. Attorney's Office for the Eastern District of Virginia (http://www.justice.gov/usao/vae). Case records may be found on PACER (https://pacer.uscourts.gov/) under case number 1:25-cv-450-MSN-LRV.
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Original text here: https://www.justice.gov/usao-edva/pr/lobbying-firm-and-its-owner-ordered-pay-400000-fraudulently-obtained-paycheck
FDA Center for Tobacco Products Issues Warning Letter to Smart Vending Services
WASHINGTON, April 15 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Smart Vending Services LLC from its Center for Tobacco Products:* * *
Recipient: Smart Vending Services, LLC, 121 Industrial Park Road Suite 102, Henderson, NV 89015, United States
Issuing Office: Center for Tobacco Products, United States
WARNING LETTER
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed our inspection records and determined that Smart Vending Services, LLC sells ... Show Full Article WASHINGTON, April 15 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Smart Vending Services LLC from its Center for Tobacco Products: * * * Recipient: Smart Vending Services, LLC, 121 Industrial Park Road Suite 102, Henderson, NV 89015, United States Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed our inspection records and determined that Smart Vending Services, LLC sellsand/or distributes nicotine pouch products to customers in the United States.
Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Sec. 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source and intended for human consumption. Certain tobacco products, including nicotine pouch products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. Sec. 387a(b)) and 21 C.F.R. Sec. 1100.1, and are required to be in compliance with the requirements in the FD&C Act.
Generally, to be legally marketed in the United States, the FD&C Act requires "new tobacco products" to have a premarket authorization order in effect. A "new tobacco product" is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. Sec. 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. Sec. 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. Sec. 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. Sec. 387e(j)(3)).
New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded
FDA has determined that you offer for sale or distribution to customers in the United States nicotine pouch products that lack a marketing authorization order, including: HYPPE Wintergreen 8 mg.
The tobacco product listed above is a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007. This product does not have an FDA marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt from the marketing authorization requirement. Therefore, this product is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. Sec. 387b(6)(A)). In addition, it is misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. Sec. 387c(a)(6)) because a notice or other information respecting this product was not provided as required by section 905(j) of the FD&C Act.
Conclusion and Requested Actions
FDA has determined that your firm markets new tobacco products in the United States that lack premarket authorization. All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA's discretion.
For a list of products that received marketing granted orders, please visit our website: https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/tobacco-products-marketing-orders#PMTAView%20all%20marketing%20granted.
It is your responsibility to ensure that all tobacco products you sell and/or distribute in the United States and all related labeling and/or advertising on any websites or other media (such as e-commerce, social networking, or search engine websites), and in any retail establishments in which you advertise, comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. Sec. 301 et seq. or its implementing regulations relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, or 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. However, this Warning Letter does not constitute "written notice" for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that tobacco products offered for import into the United States that appear to be adulterated and/or misbranded may be detained or refused admission.
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should take prompt action to address any violations that are referenced above, as well as violations that are the same as or similar to the ones stated above, and take any necessary actions to bring these tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring these products into compliance, including the dates on which you discontinued the violative sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that these products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA's homepage at http://www.fda.gov.
Please note your reference number, ER2601430, in your response and direct your response to the following address:
DEM-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/S/ Ibarra-Pratt, Ele, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/smart-vending-services-llc-724469-04072026
FDA Center for Tobacco Products Issues Warning Letter to Mohawksmoke.com
WASHINGTON, April 15 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to mohawksmoke.com from its Center for Tobacco Products:* * *
Recipient: mohawksmoke.com, United States, info@mohawksmoke.com, support@mohawkvape.com
Issuing Office: Center for Tobacco Products, United States
WARNING LETTER
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://mohawksmoke.com and determined that nicotine pouch products listed there are offered for sale ... Show Full Article WASHINGTON, April 15 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to mohawksmoke.com from its Center for Tobacco Products: * * * Recipient: mohawksmoke.com, United States, info@mohawksmoke.com, support@mohawkvape.com Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://mohawksmoke.com and determined that nicotine pouch products listed there are offered for saleor distribution to customers in the United States.
Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Sec. 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source and intended for human consumption. Certain tobacco products, including nicotine pouch products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. Sec. 387a(b)) and 21 C.F.R. Sec. 1100.1 and are required to be in compliance with the requirements in the FD&C Act.
Generally, to be legally marketed in the United States, the FD&C Act requires "new tobacco products" to have a premarket authorization order in effect. A "new tobacco product" is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. Sec. 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. Sec. 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. Sec. 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. Sec. 387e(j)(3)).
New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded
FDA has determined that you offer for sale or distribution to customers in the United States nicotine pouch products that lack a marketing authorization order: Zyn Nicotine Pouches 11mg - Apple Mint and Zyn Nicotine Pouches 11mg - Strawberry Cake.
The tobacco products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. Sec. 387b(6)(A)). In addition, they are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. Sec. 387c(a)(6)) because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)).
Conclusion and Requested Actions
FDA has determined that your firm markets new tobacco products in the United States that lack premarket authorization. All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA's discretion.
For a list of all products that have been authorized by the FDA and certain others that may be legally marketed, please visit the Searchable Tobacco Products Database: https://www.fda.gov/searchtobacco.
It is your responsibility to ensure that all tobacco products you sell and/or distribute in the United States and all related labeling and/or advertising on any websites or other media (such as e-commerce, social networking, or search engine websites), and in any retail establishments in which you advertise, comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. Sec. 301 et seq., or its implementing regulations relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. However, this Warning Letter does not constitute "written notice" for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that tobacco products offered for import into the United States that appear to be adulterated and/or misbranded may be detained or refused admission.
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should take prompt action to address any violations that are referenced above and take any necessary actions to bring these tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring these products into compliance, including the dates on which you discontinued the violative sale and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that these products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA's homepage at https://www.fda.gov.
Please note your reference number, RW2602400, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/S/ Ele Ibarra-Pratt, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
Internet Domain Service BS Corp
abuse@internet.bs
Cloudflare, Inc.
abuse@cloudflare.com
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mohawksmokecom-726970-04032026
FDA Center for Drug Evaluation & Research Issues Warning Letter to Rxgoodusa
WASHINGTON, April 15 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Rxgoodusa from its Center for Drug Evaluation and Research:* * *
Recipient: Rxgoodusa, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
MARCS-CMS 723622
Rxgoodusa:
This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.rxgoodusa.com and has observed that your website introduces into interstate commerce ... Show Full Article WASHINGTON, April 15 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Rxgoodusa from its Center for Drug Evaluation and Research: * * * Recipient: Rxgoodusa, United States Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER MARCS-CMS 723622 Rxgoodusa: This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.rxgoodusa.com and has observed that your website introduces into interstate commercemisbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. Sec.Sec. 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)]. FDA previously issued a Warning Letter to you on August 1, 2025, addressing similar violations while you were operating under www.usaquickmeds.com.1 Your continued introduction into interstate commerce of misbranded and unapproved new drugs after receipt of that Warning Letter raises significant concerns regarding your compliance with the FD&C Act.
As discussed below, FDA has observed that www.rxgoodusa.com introduces into interstate commerce unapproved and misbranded opioids. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.
FDA has also observed that www.rxgoodusa.com introduces into interstate commerce unapproved and misbranded benzodiazepines. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co-use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co-used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines.
There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.rxgoodusa.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.
Unapproved New Drugs:
Certain products offered for sale by www.rxgoodusa.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. Sec. 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. Sec. 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. Sec. 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. Sec.Sec. 331(d) and 355(a)].
An example of an unapproved opioid you offer for sale on www.rxgoodusa.com is tramadol marketed as "Citra 100mg (Loose Pills) - US TO US Tramadol". Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims "Citra Tramadol (Loose Pills)is used to deal with moderate to severe pain. It is an opioid analgesic medicine used for the short term to feel relieved from different painful conditions." While there are FDA-approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "Citra 100mg (Loose Pills) - US TO US Tramadol" offered by www.rxgoodusa.com. FDA-approved tramadol is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
FDA-approved tramadol is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning, commonly referred to as a "black box warning," which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. This boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when these drug products are taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death.
An example of unapproved benzodiazepine you offer for sale on www.rxgoodusa.com is diazepam marketed as "Diazepam 10mg US to US". Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims "DIAZEPAM (dye AZ e pam) treats seizures, muscle spasms or twitches. It may also be used to treat anxiety, including before a procedure." While there are FDA-approved versions of diazepam on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "Diazepam 10mg US to US" offered by www.rxgoodusa.com. FDA-approved diazepam (VALIUM(R)) is indicated for the management of anxiety disorders, acute alcohol withdrawal symptom relief, as adjunctive therapy for skeletal muscle spasm relief, and as adjunctive therapy in convulsive disorders.
FDA-approved diazepam is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning, addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
Misbranded Drugs:
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. Sec. 352(f)(1)] if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. Sec. 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. Sec. 353(b)(1)(A)], can be used safely only at the direction, and under the supervision, of a licensed practitioner.
Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. Sec. 352(f)(1)]. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act [21 U.S.C. Sec. 352(f)(1)]. By offering these drugs for sale to U.S. consumers, www.rxgoodusa.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. Sec. 331(a)].
Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug products without requiring a prescription, www.rxgoodusa.com jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act [21 U.S.C. Sec. 353(b)(1)]. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. Sec. 331(k)].
FDA is sending this warning letter to www.rxgoodusa.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.
If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.
Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
Sincerely,
/S/ Sangeeta Vaswani Chatterjee, Pharm.D., Director, Office of Drug Security, Integrity, and Response, Office of Compliance, Center for Drug Evaluation and Research
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Footnote:
1/ Warning Letter to www.usaquickmeds.com (Aug. 1, 2025), available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wwwusaquickmedscom-713312-08012025
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rxgoodusa-723622-04012026
FDA Center for Drug Evaluation & Research Issues Warning Letter to Purolea Cosmetics Lab
WASHINGTON, April 15 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Purolea Cosmetics Lab from its Center for Drug Evaluation and Research:* * *
Recipient: Ms. Maria N. Mattina, Owner/President, Purolea Cosmetics Lab, 12782 Currie Ct., Livonia, MI 48150-1109, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-58
Dear Ms. Mattina:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Purolea Cosmetics Lab, FEI 3011669383, ... Show Full Article WASHINGTON, April 15 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Purolea Cosmetics Lab from its Center for Drug Evaluation and Research: * * * Recipient: Ms. Maria N. Mattina, Owner/President, Purolea Cosmetics Lab, 12782 Currie Ct., Livonia, MI 48150-1109, United States Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-58 Dear Ms. Mattina: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Purolea Cosmetics Lab, FEI 3011669383,at 12782 Currie Ct., Livonia, from October 28 to 30, 2025.
Your drug products are adulterated under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(A), in that they have been prepared, packed, or held under insanitary conditions.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
In addition, the FDA reviewed the product labels for drug products manufactured at your facility, including "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief." Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). These drug products are especially concerning from a public health perspective as they are intended to treat serious and/or life-threatening conditions such as shingles and genital herpes.
We acknowledge receipt of your response to our Form FDA 483. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
Insanitary Conditions
Your drug products are adulterated under section 501(a)(2)(A) of the FD&C Act because they were prepared, packed, or held under insanitary conditions. During the inspection, our investigator observed the presence of insects, filth, leaves, and clutter in several areas within your facility.
Furthermore, your facility lacked adequate separation to prevent contamination from other internal or external contaminants. For example, the facility docking bay door, when opened, would directly expose manufacturing to the outside environment.
CGMP Violations
1. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)
You manufacture multiple (b)(4) homeopathic drug products. Some of these products can be used to (b)(4). Additionally, some products may be used (b)(4).
Your firm released your finished homeopathic drug products without testing for microbiological attributes (e.g., total count, objectionable microorganisms). Without testing each batch prior to release, you did not have scientific evidence that all drug product batches were free of objectionable microbial contamination.
Your firm failed to conduct testing for (b)(4) for non-sterile (b)(4) drug products prior to release and at appropriate intervals for stability. See FDA's guidance document, Microbiological Quality Considerations in Non-sterile Drug Manufacturing, for help minimizing the risks of harmful microbiological contamination of (b)(4) drugs at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/microbiological-quality-considerations-non-sterile-drug-manufacturing.
Drug products that do not meet quality standards can pose a safety risk to the public.
2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals. Your firm also failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use (21 CFR 211.84(d)(1) and 211.84(d)(2) and 211.84(d)(6)).
You failed to perform adequate testing for purity, strength, quality, and identity for the components used in the manufacture of your (b)(4) drug products. In addition, you relied on your suppliers' certificates of analysis (COA) without establishing the reliability of your component suppliers' test analyses at appropriate intervals.
(b)(4)
You failed to test your purchased bulk (b)(4) to assure it was of acceptable quality for use in drug production. You also failed to establish the reliability of your component supplier at appropriate intervals. Your firm has not demonstrated that the (b)(4) was suitable for its intended use, tested for microbiological quality, and minimally met the United States Pharmacopeia (USP) (b)(4) monograph.
(b)(4) must be suitable for its intended use. Each lot must be tested to ensure conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts as well as characterization and identification of contamination is integral to ensuring (b)(4) is of acceptable quality for use in manufacturing operations.
Of note, you did not test the (b)(4) for (b)(4), a contamination risk in (b)(4) drug products, which has been linked to (b)(4). For further information regarding the significance of (b)(4) contamination of (b)(4) drug products, see FDA's advisory notice at (b)(4).
Ingredients at Risk for (b)(4) Contamination
You failed to adequately test your incoming components at high risk of (b)(4) contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of (b)(4) to determine its appropriate identity. The identity testing of (b)(4) includes a limit test, according to the USP, to ensure that the component meets the relevant safety limits for the levels of (b)(4).
The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA's guidance document, (b)(4).
Without appropriate testing of components and ingredients, you cannot ensure the quality and safety of your drug products.
3. Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Your quality unit (QU) did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure:
* Procedures were established or followed (21 CFR 211.22(d))
* Batch records were reviewed before drug product release (21 CFR 211.22(a))
* Adequate production and process controls were established (21 CFR 211.100(a))
Your firm's quality systems are inadequate. See FDA's guidance document, Quality Systems Approach to Pharmaceutical CGMP Regulations, for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.
Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing.
During the FDA inspection of your drug manufacturing facility, you stated to FDA investigators that you utilized artificial intelligence (AI) agents (b)(4) to help your firm comply with FDA regulations. Specifically, you used AI to create drug product specifications, procedures, and master production or control records to be in compliance with FDA requirements.
If you use AI as an aid in document creation, you must review the AI generated documents to ensure they were accurate and actually compliant with CGMP. Your failure to do so is a violation of 21 CFR 211.22(c). Overreliance on artificial intelligence for your drug manufacturing operations was also documented during the inspection. For example, the FDA investigators found that you had not conducted process validation prior to distribution of your drug products, as required under 21 CFR 211.100, and informed you as such. You replied that you were not aware of the legal requirement, as the AI agent you used (b)(4), never told you it was required.
We recognize that you have ceased drug production. If you plan to resume drug production, and use AI to help with CGMP activities, such as development of procedures and specifications, any output or recommendations from an AI agent must be reviewed and cleared by an authorized human representative of your firm's QU in accordance with section 501(a)(2)(B) of the FD&C Act. See also 21 CFR 211.22; 21 CFR 211.100.
Drug Production Ceased
We acknowledge your commitment to cease production and distribution of drugs at this facility.
Even though you indicated your firm is no longer manufacturing products at your facility, there are still products within expiry in U.S. distribution. Data is required to support whether your components and your drug products meet established specifications (such as identity, strength, quality, and purity) and that these drug products will remain within acceptable limits and retain their quality attributes through their labeled shelf-life until expiry.
In response to this letter:
* Specify by National Drug Code (NDC) number which drugs have been discontinued and the last day of manufacture.
* Clarify your intentions for the drug products that remain on the market within expiry.
o Explain how distributed drug products will be verified to ensure they meet specifications.
o Confirm that if you receive any client or customer complaints and/or any results from ongoing testing or evaluation that reveal substandard quality for the drug components, active pharmaceutical ingredient (API), or distributed drug products, that rapid corrective action should be taken for products that were released for commercial distribution and that are still within expiry, such as notifying customers and product recalls.
* Provide commitment that if you intend to resume manufacturing drugs at this facility or any other facility in the future, that you will notify this office prior to resuming your drug manufacturing operations.
If you resume CGMP activities, you are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In addition, based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of all corrective action and preventive action, before you pursue resolution of your firm's compliance status with FDA.
Owner's Responsibilities
Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.
You are responsible for the quality of your drugs regardless of agreements in place with a contract facility. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA's guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.
Updates to the Electronic Drug Registration and Listing System (eDRLS)
If your firm does not intend to engage in any further drug manufacturing activities, then you, as the owner and operator of the drug manufacturing establishment, are required to update all outdated information to avoid miscommunication or errors. Consequently, your firm will need to modify the drug product marketing status and delist each product with the last lot expiry date as the "marketing end date" on the specific product listing per 21 CFR 207.57(b)(1)(ii).
Additionally, after delisting your drug products, you will need to deregister your overall drug establishment with FDA if you cease manufacturing and distributing drugs in U.S. per 21 CFR 207.29(a)(1). If you have any further registration or listing questions, please contact the EDRLS general mailbox: eDRLS@fda.hhs.gov.
Unapproved New Drugs
Based on a review of the product labels collected during the inspection, "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples of claims from the product labels that provide evidence of the intended uses (as defined in 21 CFR 201.128) of these products as drugs include, but are not limited to, the following:
Dermveda Extra Strength Shingles Relief
* "SHINGLES"
Dermveda Extra Strength Ultra Genital Herpes Relief
* "GENITAL HERPES RELIEF"
"Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" are "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
We recognize that "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" are labeled as homeopathic drugs. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term "drug" includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.
Cosmetics Manufactured for Distribution in the United States
In addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.
We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA's regulations through links on FDA's website at www.fda.gov.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.
Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3011669383 and ATTN: Frank Wackes.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
/S/ Tina Smith, Captain, U.S. Public Health Service, Director, Office of Unapproved Drugs & Labeling Compliance, Office of Compliance, Center for Drug Evaluation and Research
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purolea-cosmetics-lab-722591-04022026