FDA WARNING_LETTER - Polaroisin International Co., Ltd. - September 15, 2017

The FDA issued a Warning Letter to Polaroisin International Co., Ltd. following an inspection from September 11-15, 2017, identifying significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). Consequently, the firm's drug products are deemed adulterated under 21 U.S.C. 351(a)(2)(B). Key deficiencies include the failure to conduct appropriate laboratory determination of satisfactory conformance to final specifications for drug products, including identity and strength of active ingredients, prior to release (21 CFR 211.165(a)). The firm also failed to ensure the identity of incoming components and lacked a supplier qualification program (21 CFR 211.84(d)(1) and (2)). Furthermore, there was no appropriate stability testing to support drug product expiration dates (21 CFR 211.137(a)), and the firm failed to establish written procedures for production and process control, specifically lacking process performance qualification studies (21 CFR 211.100(a)). The letter also noted that the firm's OTC drug products, particularly (b)(4) products, did not comply with the Final Rule for (b)(4) Drug Products for Over-the-Counter Human Use, including active ingredient limitations and Drug Facts panel requirements (21 CFR 201.66). The FDA recommended engaging a qualified consultant. Due to these violations, the firm was placed on Import Alert 66-40, and FDA may withhold approvals of new applications and refuse admission of products into the U.S. The firm must provide a written response within 15 working days detailing corrective actions and timelines.