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

During an inspection from February 3-7, 2025, the FDA observed significant deficiencies at Pharmazell (India) Private Ltd, an API manufacturer in Visakhapatnam. The primary concern was the firm's failure to conduct proper installation, operation, and performance qualification studies for multiple pieces of manufacturing equipment. This indicates a lapse in ensuring equipment is fit for its intended use in producing active pharmaceutical ingredients.