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

During an inspection conducted from February 3-7, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Pharmazell (India) Private Ltd, an Active Pharmaceutical Ingredient (API) manufacturer located in Visakhapatnam, Andhra Pradesh, India. The inspection revealed significant observations concerning the routine checking and qualification of manufacturing equipment. Specifically, the FDA noted that the company failed to perform protocol-driven Installation Qualification (IQ) and Operational Qualification (OQ) studies for various equipment used in specific manufacturing processes. Additionally, the inspection identified a lack of current Performance Qualification (PQ) for multiple manufacturing equipment, with the last recorded qualification dating back to October 27, 2009. These findings indicate a deficiency in maintaining an adequate program to assure the proper performance of equipment, which is critical for ensuring product quality and adherence to Good Manufacturing Practices (GMP). Pharmazell (India) Private Ltd is now required to provide a comprehensive response to the FDA detailing the corrective and preventive actions planned to address these inspectional observations.