FDA 483 - Samsung Biologics Co., Ltd.

An FDA inspection of Samsung Biologics Co., Ltd. in Incheon, Korea, revealed significant deficiencies across multiple areas of their drug manufacturing operations. Key issues included inadequate data integrity controls in the MSAT laboratory, failures to follow written procedures for aseptic processing, and a deficient Quality Unit. The inspection also cited problems with equipment revalidation and facility maintenance, indicating a broad scope of non-compliance.