Amneal Pharmaceuticals Private LimitedMay 2, 2023

FDA 483 - Amneal Pharmaceuticals Private Limited - May 02, 2023

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Record Details

Puniska Healthcare Private Limited, a sterile drug manufacturer in Pipan, Gujarat, received a Form 483 with two observations. The inspection revealed deficiencies in written quality control procedures for packaging operations and inadequate laboratory controls regarding the stability of solutions used in testing. These issues indicate a lack of robust systems to ensure drug product quality and integrity.

Company: Amneal Pharmaceuticals Private Limited
Inspection Date: May 2, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Jose F. Velez

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ID · 2987eff4-fdf3-47b8-9930-1a278737dbab