FDA 483 - Aso Pharmaceutical Company, Ltd - September 08, 2023

Aso Pharmaceutical Company, Ltd. was issued an FDA Form 483 following an inspection from September 4-8, 2023, highlighting significant deviations from current Good Manufacturing Practices (cGMP). The inspection identified six main areas of concern, requiring prompt corrective action. Primary violations included inadequate laboratory controls, specifically the absence of impurity specifications and microbial limit tests for Over-the-Counter (OTC) drug products released to the U.S. market. The firm's investigations into out-of-specification (OOS) results and customer complaints were found deficient, often lacking thorough root cause determination or effective follow-up actions. Furthermore, Aso Pharmaceutical failed to consistently record and justify deviations from established production and process control procedures, evidenced by incomplete process validation for material changes and unaddressed analyst errors. Additional issues encompassed a failure to establish adequate written procedures for production and process controls, including insufficient manufacturing process validation and incomplete batch records. Environmental control and facility maintenance were also noted as inadequate, with observations of disrepair, dust accumulation, and potential mold in production areas. Lastly, the company's stability program was found lacking, as product expiration dating relied on samples stored in container-closure systems different from those used for marketed products. Aso Pharmaceutical Company, Ltd. must now provide a detailed response outlining comprehensive corrective and preventive actions to rectify these regulatory non-compliances.