483
Hanmi Pharma Co., LtdFDA 483 - Hanmi Pharma Co., Ltd - July 05, 2022
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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