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

An FDA inspection of Haw Par Healthcare Limited, an OTC Drug Manufacturer in Singapore, revealed seven significant observations related to quality control and manufacturing practices. The firm failed to thoroughly investigate out-of-specification results for product impurities, lacked an adequate microbiology testing program, and exhibited poor traceability for drug product lots. Additionally, deficiencies were noted in establishing bulk hold times, managing complaint records, conducting supplier audits, and accurately identifying raw material statuses in their SAP system, indicating a need for improved quality systems.