Steril-Gene Life Sciences Private LtdDecember 10, 2019

FDA 483 - Steril-Gene Life Sciences Private Ltd - December 10, 2019

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Record Details

Steril-Gene Life Sciences Pvt Ltd, a contract sterile drug product manufacturer in Puducherry, India, was cited with two observations during an FDA inspection. The observations concern failures to follow written production procedures, specifically regarding visual inspection of vials, and deficiencies in cleaning and maintenance procedures for equipment, including inadequate cleaning validation sampling plans for manufacturing tanks.

Company: Steril-Gene Life Sciences Private Ltd
Inspection Date: December 10, 2019
Product Type: Drugs
Office: Foreign - CVM (Bioresearch Monitoring)
Person: Jose F. Velez

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