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

Source: https://www.globalkeysolutions.net/records/483/taro-pharmaceutical-industries-ltd/44cf6f3a-f2c6-40a3-9ff7-7b622a9d7d8b

> FDA 483 for Taro Pharmaceutical Industries, Ltd. on July 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Taro Pharmaceutical Industries, Ltd.
- Inspection Date: 2019-07-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Yvesna Blaise](https://www.globalkeysolutions.net/people/yvesna-blaise/4cd6b7c2-78a7-490d-9354-52046bc7344f)

Company: https://www.globalkeysolutions.net/companies/taro-pharmaceutical-industries-ltd/75bff305-a575-43eb-9c35-401fed5479be

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1