FDA WARNING_LETTER - Optikem International, Inc. - March 01, 2024

On August 13, 2024, the FDA issued a Warning Letter to Ms. Cook, manufacturer of Sereine brand ophthalmic medical device solutions, following an inspection from February 26 to March 1, 2024. The inspection revealed the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to adequately validate processes for sterile devices (21 CFR 820.75):** The Process Validation procedure is inadequate, lacking requirements for qualified individuals and complete documentation. Aseptic media fills and mixing/heat treatment validation have not been performed since 2021. The firm's response was deemed inadequate, lacking timelines or evidence of corrective action. 2. **Failure to routinely calibrate equipment for sterile devices (21 CFR 820.70):** The Inspection, Measuring and Testing Equipment procedure is inadequate, lacking specific directions, limits, and remedial actions. A temperature recorder has not been calibrated since 2016, a recurring violation since 2017. The firm's response was inadequate. 3. **Failure to establish and implement design control procedures (21 CFR 820.30):** The Design Controls procedure was not implemented for the