483
Sumika Chemical Analysis Service, Ltd.Sumika Chemical Analysis Service, Ltd. – FDA 483, Nov 13, 2019
Record Details
An FDA inspection of Sumika Chemical Analysis Service, Ltd., a contract testing laboratory in Oita, Japan, revealed a critical data integrity issue. The firm failed to ensure that backup data from stand-alone analytical instruments was secure from alteration, erasure, or loss. This deficiency impacts the reliability of testing data for various APIs and drug products supplied to the US market.
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ID · e076b85e-9fa6-41c7-ac5b-55fe37a759c0
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