Pharmazell (India) Private LtdFebruary 7, 2025

FDA 483 - Pharmazell (India) Private Ltd - February 07, 2025

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Record Details

An FDA inspection of Pharmazell (India) Private Ltd's API manufacturing facility in Visakhapatnam revealed significant deficiencies in equipment qualification. The firm failed to conduct proper installation, operational, and performance qualification studies for multiple manufacturing equipment. This indicates a lack of adherence to a written program designed to assure proper equipment performance.

Company: Pharmazell (India) Private Ltd
Inspection Date: February 7, 2025
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Olumide A. Akinyemi
Jessica S. Estriplet (Drug Investigator)

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