483
Sakai Chemical Industry Co., Ltd.Sakai Chemical Industry Co., Ltd. – FDA 483, Nov 17, 2023
Record Details
An FDA inspection of Sakai Chemical Industry Co., Ltd. in Iwaki, Japan, revealed significant deficiencies in their Quality Unit's operations. The firm failed to adequately investigate laboratory errors and out-of-specification results, and did not properly justify changes to test specifications. Additionally, required change control procedures were not initiated for these critical changes.
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ID · fdd1be48-5803-4327-97c8-f66210f99e47
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