FDA WARNING_LETTER - Shanghai Weierya Daily Chemicals Factory - April 14, 2017

The FDA inspected Shanghai Weierya Daily Chemicals Factory from April 10-14, 2017, identifying significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key deficiencies included the firm's failure to conduct appropriate laboratory testing for objectionable organisms for each batch of drug product (21 CFR 211.165(b)), ensure the identity of all incoming components including active ingredients and excipients (21 CFR 211.84(d)(1)), and establish an adequate quality control unit with proper authority to approve or reject materials and review records (21 CFR 211.22(a)). The firm's May 7, 2017, response was deemed inadequate. The FDA requires a comprehensive plan for microbiological testing of all OTC drug product batches, a detailed sampling and testing plan for incoming components, a summary of quality unit procedures, and a thorough CGMP assessment with a corrective and preventive action plan. A CGMP consultant is strongly recommended. The firm was placed on Import Alert 66-40, and failure to correct violations may lead to continued refusal of admission of products into the U.S. and withholding of new drug application approvals. A written response is required within 15 working days.