483
Alps Pharmaceutical Industrial Co., Ltd.Alps Pharmaceutical Industrial Co., Ltd. – FDA 483, May 26, 2023
Record Details
An FDA inspection of Alps Pharmaceutical Industrial Co. Ltd. in Hida, Gifu, Japan, an Active Pharmaceutical Ingredient (API) Manufacturer, revealed significant deficiencies. The firm failed to validate its cGMP-related software system, lacked controls for authentic personnel signatures on cGMP documents, and did not verify analytical methods for finished product testing after instrument changes.
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ID · 1b59829d-c79f-4e56-afa9-dfea63eb6153
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