483
Western Chemical Inc.Western Chemical Inc. – FDA 483, Oct 23, 2024
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.
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ID · 280cc34d-d232-44d9-9a48-121e7abb424b
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