FDA 483 - Haw Par Healthcare Limited - September 27, 2024

During an inspection conducted from September 23-27, 2024, the U.S. Food and Drug Administration (FDA) identified significant manufacturing deficiencies at Haw Par Healthcare Limited, an OTC drug manufacturer located in Singapore. The inspection revealed multiple issues indicating a lack of adherence to Good Manufacturing Practices (GMP) regulations. Key observations included a failure to thoroughly investigate out-of-specification results for product impurities, with inadequate testing across all production lots and insufficient traceability due to problematic batch numbering. The company also lacked an adequate microbiology testing program for its drug product, including insufficient testing frequency and missing method suitability and antimicrobial effectiveness tests. Further issues involved the absence of unique lot identification for finished drug products, leading to challenges in historical traceability, and the storage of unlabeled product. Production processes suffered from a lack of established hold times for critical manufacturing phases. Additionally, complaint records were deficient, missing entries and lacking proper documentation for cancelled investigations. The firm also failed to follow its own written procedures for supplier audits of critical raw materials and primary packaging. Finally, the system for identifying raw material status was inadequate, allowing potentially unrestricted use of untested or out-of-specification components. Haw Par Healthcare Limited must address these observations to ensure the quality, safety, and regulatory compliance of its drug products.