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483
•Taro Pharmaceuticals Inc.•September 16, 2022

Taro Pharmaceuticals Inc. – FDA 483, Sep 16, 2022

Record Details

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.

Company
Taro Pharmaceuticals Inc.
Inspection date
September 16, 2022
Product type
drugs
Office
Office of Biological Products Operations - Division I
Person
  • Marian E. Ramirez (investigator)
View Company Profile

ID · bb5cda45-9f89-42a6-9724-d0f098043f78

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