Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3031057987.
Violations4
Issue DateAug 18, 2026
Product TypeDrugs
StatusOpen
Letter Details
Firm
PReye, LLC
Location
PReye, LLC, 4855 Ward Rd. Wheat Ridge , CO 80033 United States, (b)(6)
FEI Number
3031057987
Country
United States
Issue Date
August 18, 2026
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Subject
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
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