FDA 483 - TAIWAN BIOTECH CO., LTD. - September 20, 2022

During an inspection from September 12-20, 2022, the FDA issued a Form 483 to TAIWAN BIOTECH CO., LTD., a sterile drug manufacturer. The observations highlight significant deviations from regulatory expectations, particularly concerning Good Manufacturing Practices.

Key issues include the quality control unit's failure to adhere to written procedures. Specifically, an API vendor used since 2011 was never qualified. Analytical data was recorded non-contemporaneously, away from the laboratory, violating standard operating procedures. The company's Corrective and Preventive Action (CAPA) system was deficient, as not all CAPAs, including Out-of-Specification (OOS) investigations, were logged or subjected to effectiveness checks. Furthermore, critical environmental monitoring incubators lacked qualified low-temperature alarms, had unidentifiable temperature chart recordings, and were manually monitored only on weekdays, including being powered off for maintenance without impact assessments. The firm also failed to timely initiate stability studies for finished products, with samples sometimes delayed by months.

Additionally, the inspection found that stability testing results were not appropriately utilized to determine storage conditions and expiration dates. A reduced shelf life for a sterile product was not adequately assessed for its impact on batches already on the market. Stability studies for another product were conducted under limited conditions (250C/60% RH) not fully reflective of the labeled "room temperature" storage, and previous comprehensive studies were outdated. TAIWAN BIOTECH CO., LTD. is expected to promptly address these observations to ensure compliance with regulatory requirements.