FDA 483 - Hanmi Fine Chemical Co Ltd - June 11, 2018

Hanmi Fine Chemicals Co., Ltd., an API manufacturer in Gyeonggi-Do, Republic of Korea, was cited for significant deficiencies across its quality systems. Observations included inadequate cleaning validation, issues with stability sample storage and traceability, insufficient computer system controls, and failures in deviation management and equipment qualification. The firm also lacked documented training and sufficient data to support retest/expiry dates.