Par Formulations Private LimitedApril 5, 2022

FDA 483 - Par Formulations Private Limited - April 05, 2022

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Record Details

Par Formulations Private Limited, a drug manufacturer in Dhar, India, was inspected by the FDA from March 29 to April 5, 2022. The inspection revealed significant deficiencies in equipment cleaning, personnel gowning practices, and laboratory control mechanisms for glassware, indicating potential contamination risks for drug products intended for the US market.

Company: Par Formulations Private Limited
Inspection Date: April 5, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Saleem A. Akhtar

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ID · 400bbc4f-1742-4da7-8c2c-262920e13ee5