483
Hanmi Pharma Co., LtdHanmi Pharma Co., Ltd – FDA 483, Jul 5, 2022
Record Details
An FDA inspection of Hanmi Pharm. Co., Ltd., a drug substance manufacturer in Pyeongtaek-si, Gyeonggi-do, Republic of Korea, identified two observations. The firm was cited for an unqualified temperature-controlled storage area for cGMP materials and inadequate procedural controls for handling and documenting in-process materials.
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ID · a90a9884-ea18-4aae-aee7-6b308b7948ba
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