483
Hanmi Pharma Co., LtdFDA 483 - Hanmi Pharma Co., Ltd - February 01, 2018
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Record Details
An FDA inspection of Hanmi Pharma Co., Ltd in Pyeongtaek-si, Korea, revealed inadequate document control procedures. Specifically, quality system document changes lacked consistent descriptions and sufficient documentation for adequate review prior to approval. This deficiency led to critical preventive maintenance checks being inadvertently removed from equipment checklists.
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ID · 658a1814-5e4e-4311-9021-e5669c8c42d7