FDA 483 - Zhaoke Pharmaceutical (Hefei) Company Limited - June 18, 2024

An FDA inspection of Zhaoke Pharmaceutical (Hefei) Company Limited, a sterile drug manufacturer in Hefei, China, revealed significant deficiencies across its operations. Observations included incomplete laboratory records for microbial counts, inadequate laboratory controls for endotoxin and filter integrity, and insufficient validation of aseptic and sterilization processes. The firm also failed to establish and follow proper aseptic procedures, maintain equipment, and ensure data integrity with audit trails.