483
Taro Pharmaceutical Industries, Ltd.Taro Pharmaceutical Industries, Ltd. – FDA 483, Jul 11, 2019
Record Details
An FDA inspection of Taro Pharmaceutical Industries, Ltd. in Haifa, Israel, revealed a significant quality system deficiency. The firm failed to adequately investigate unexplained discrepancies and batch failures, specifically by not extending investigations to other batches of the same drug product. This lapse resulted in the release and distribution of potentially compromised drug product without proper risk assessment or testing.
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ID · 44cf6f3a-f2c6-40a3-9ff7-7b622a9d7d8b
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