FDA 483 - Taro Pharmaceutical Industries, Ltd. - July 11, 2019

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.