FDA 483 - Haw Par Healthcare Limited - August 19, 2022

An FDA inspection of Haw Par Healthcare Limited, an OTC drug manufacturer in Singapore, revealed significant deficiencies across its quality, production, facilities, and laboratory control systems. The firm failed to adequately investigate out-of-specification results, lacked proper process and cleaning validations, and did not follow or contemporaneously document production procedures. Several observations, including issues with production documentation and hold times, were repeat findings from a previous inspection, indicating persistent non-compliance.