# FDA 483 - Taro Pharmaceuticals Inc. - September 16, 2022

Source: https://www.globalkeysolutions.net/records/483/taro-pharmaceuticals-inc/bb5cda45-9f89-42a6-9724-d0f098043f78

> FDA 483 for Taro Pharmaceuticals Inc. on September 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Taro Pharmaceuticals Inc.
- Inspection Date: 2022-09-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Taro Pharmaceuticals Inc. in Brampton revealed significant deficiencies in manufacturing controls. The firm failed to establish adequate written procedures for in-process controls during packaging and did not consistently follow its own standard operating procedures for initiating and investigating deviations. These issues indicate a lack of robust quality system oversight.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.globalkeysolutions.net/companies/taro-pharmaceuticals-inc/2072a3d5-a0ae-4bb7-9375-a6406a4fd768

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