Cosco International, Inc. – FDA Warning Letter, Oct 25, 2024

The FDA inspected Cosco International Inc. in Marietta, GA, from October 15-25, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR parts 210 and 211, rendering drug products adulterated. Key CGMP deficiencies included failure to establish adequate written procedures for production and process control, specifically lacking process and cleaning validation (21 CFR 211.100(a)). The firm also failed to implement an adequate stability testing program (21 CFR 211.166(a)) and lacked appropriate laboratory controls, including scientifically sound specifications and testing for (b)(4) water (21 CFR 211.160(b)). Furthermore, the quality control unit failed to ensure CGMP compliance and product specifications (21 CFR 211.22). Beyond CGMP, the products “(b)(4),” “Carpe ANTIPERSPIRANT FOOT LOTION,” and “Carpe ANTIPERSPIRANT HAND LOTION” were cited as unapproved new drugs (sections 505(a) and 301(d) FD&C Act) and misbranded (section 502(ee) FD&C Act) because they do not conform to applicable OTC monographs regarding active ingredients or intended use. The FDA recommends engaging a qualified CGMP consultant to evaluate operations and assist with corrective actions. The firm must respond within 15 working days, detailing corrective and preventive actions. Failure to address these violations may result in regulatory actions, including seizure, injunction, and impact on export certificates or application approvals.