PReye, LLC
FDA issued a warning letter to PReye, LLC (owner Dr. Melinda C. O'Rourke, Wheat Ridge, CO) following a March 2026 inspection and June 2026 website review. The company was found to be manufacturing and distributing 'PReye Vitamin SEE,' an ophthalmic eye drop product, under grossly inadequate aseptic conditions (non-certified flow hood in an unclassified office space) and without a functioning quality unit, constituting CGMP violations under 21 CFR parts 210 and 211. The product was also deemed an unapproved new drug under FD&C Act section 505(a) based on disease-treatment and prevention claims made on the company website. The company had already voluntarily recalled the product in May 2026 and committed to cease manufacturing, but FDA required a written response within 15 business days and warned that failure to address violations could result in seizure, injunction, and withholding of future approvals.
Flagged claims (2)
Both Ascorbic Acid and Acetylcysteine have been used independently to treat pathology in the eye, including corneal alkali burns and filamentary keratitis in severe dry eye. But, never have they been combined as a vitamin supplement eyedrop to prevent eye disease related to UV exposure, including cataracts and macular degeneration.
Antioxidant Vitamins provide protection against the damaging effects of UV light from sun exposure. . . . In the eye, UV light ages all the structures. Ocular surface damage, cataracts and macular degeneration are all possible effects from UV exposure and can ultimately lead to decreased vision, and blindness.
Required actions (4)
Send your written response to [email protected] within fifteen (15) business days of receipt of this letter.
If you plan to resume any drug manufacturing operations, including repackaging, notify this office before commencing operations.
On May 18, 2026, you issued a voluntary recall of PReye Vitamin SEE due to lack of sterility testing.
Failure to adequately address violations may result in regulatory action without further notice including, without limitation, seizure and injunction.
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