FDA 483 - Haw Par Healthcare Limited - March 01, 2019

Haw Par Healthcare Limited in Singapore was inspected by the FDA from February 25 to March 1, 2019, and received 14 observations. The inspection revealed significant deficiencies in quality control, laboratory practices, data integrity, facility maintenance, and production controls, including repeat observations related to inadequate OOS investigations. These issues indicate a systemic failure to adhere to cGMP requirements for OTC drug manufacturing.