FDA WARNING_LETTER - Pharmedica USA, LLC - November 07, 2022

On April 28, 2023, the FDA issued a Warning Letter to Pharmedica USA, LLC, following an inspection from November 1-7, 2022. The facility's drug products were deemed adulterated under 21 U.S.C. 351(a)(2)(A) due to insanitary conditions, specifically lacking ISO-classified areas for sterile drug manufacturing and being in disrepair. The products were also adulterated under 21 U.S.C. 351(a)(2)(B) for significant Current Good Manufacturing Practice (CGMP) violations.

Key violations included: 1. Failure to establish and follow written procedures for preventing microbiological contamination of sterile drug products, including validation of aseptic and sterilization processes (21 CFR 211.113(b) & 211.42(c)(10)). The firm manufactured multi-dose, preservative-free ophthalmic products without adequate controls, and admitted unawareness of sterility requirements for eye drops. 2. Failure to establish adequate written procedures for production and process control, including equipment qualification and process validation (21 CFR 211.100(a)). 3. Failure to conduct appropriate laboratory determination of conformance to final specifications, including sterility testing for sterile products and testing for objectionable microorganisms (21 CFR 211.165(