FDA WARNING_LETTER - PReye, LLC - March 19, 2026

PReye, LLC, owned by Dr. Melinda C. O’Rourke, received a formal warning letter from the FDA following an inspection of its Wheat Ridge, Colorado facility from March 17 to 19, 2026. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act and Current Good Manufacturing Practice (CGMP) regulations. The primary violations involved unsafe production conditions for sterile eye drops, which were repackaged in an uncertified flow hood within a standard office space lacking proper air filtration. Additionally, the firm failed to establish a quality control unit or implement essential procedures for product testing, cleaning, and batch traceability. The FDA also determined that the product "PReye Vitamin SEE" was being marketed as an unapproved new drug because its labeling claimed it could treat or prevent conditions such as cataracts and macular degeneration without federal approval. Although the company initiated a voluntary recall and ceased manufacturing in May 2026, the FDA mandates specific corrective actions. PReye, LLC must provide a written response within 15 business days detailing its remediation efforts. If the firm intends to resume drug manufacturing, it must notify the FDA in advance, hire a qualified consultant to perform a comprehensive audit of its systems, and demonstrate full compliance with safety standards. Failure to resolve these issues may lead to legal action, including product seizures or injunctions.