Wednesday - September 2, 2026
FDA Center for Drug Evaluation & Research Issues Warning Letter to PReye
September 02, 2026
WASHINGTON, Sept. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to PReye LLC from its Center for Drug Evaluation and Research:

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Recipient: Dr. Melinda C. O'Rourke, Owner, PReye, LLC, 4855 Ward Rd., Wheat Ridge, CO 80033, United States, (b)(6)

Issuing Office: Center for Drug Evaluation and Research (CDER), United States

WARNING LETTER

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