The U.S. Food and Drug Administration issued a warning letter to Apotex Research Private Ltd. (ARPL) after an inspection of its Bangalore, India, manufacturing facility.
FDA identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. The letter stated the violations caused its drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
FDA investigators observed specific violations during the inspection, including, but not limited to, the following:
1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
2. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).
3. Your firm failed to establish and follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)), and
4. Your firm failed to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)) and your quality control unit failed to review and approve all drug product production and control records to determine compliance with all established, approved written procedures before a batch is released or distributed (21 CFR 211.192).
Last April, the U.S. FDA banned imports from Canadian drugmaker Apotex Inc.'s manufacturing plant in Bangalore, India for failing to conform with current good manufacturing practices.
Read the full warning letter