Amaros Co., Ltd – FDA Warning Letter, May 12, 2017

The FDA inspected Amaros Co., Ltd.'s drug manufacturing facility from May 8-12, 2017, revealing significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR parts 210 and 211, rendering their drug products adulterated per 21 U.S.C. 351(a)(2)(B). The firm's response acknowledged the observations but lacked specific corrective actions. Key deficiencies include the failure to establish an adequate quality control unit with proper authority to approve or reject materials and products, including those from contract manufacturers (21 CFR 211.22(a) and (d)). The firm also lacked essential written procedures for complaints, deviations, change control, supplier qualification, and batch release, leading to some drugs being distributed without confirmed active ingredient identity and strength. Additionally, Amaros failed to implement written procedures for the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials (21 CFR 211.122(a)), and used an unvalidated sampling method. The FDA emphasized that manufacturers are responsible for drug quality regardless of contract agreements and strongly recommended engaging a qualified CGMP consultant. Consequently, Amaros Co., Ltd. was placed on Import Alert 66-40 on August 23, 2017. Failure to correct these violations may result in continued refusal of product admission into the U.S. and withholding of new application approvals. The firm must submit a detailed response within 15 working days outlining corrective actions and a completion schedule.