Western Chemical Inc.October 23, 2024

FDA 483 - Western Chemical Inc. - October 23, 2024

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Record Details

Western Chemical Inc., a manufacturer of veterinary drugs and APIs, received a Form 483 citing a significant quality control deficiency. The inspection revealed a failure to thoroughly investigate out-of-specification results for products like Syncaine and Tricaine Methanesulfonate API, including a lack of root cause analysis and assessment of impact on distributed batches. This indicates a serious lapse in their quality system for handling product deviations.

Company: Western Chemical Inc.
Inspection Date: October 23, 2024
Product Type: Veterinary
Office: Seattle District Office
People: Aranjeet Singh (FDA_PERSONNEL)
Michael Araneta (issuing_officer)

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ID · 280cc34d-d232-44d9-9a48-121e7abb424b