FDA 483 - Blossom Pharmaceuticals - April 11, 2025

Blossom Pharmaceuticals, an OTC drug manufacturer in Bardez, Goa, India, received a Form 483 for significant GMP deficiencies. The inspection revealed systemic failures in data integrity, process and cleaning validation, equipment maintenance, laboratory controls, environmental conditions, quality unit oversight, and personnel training. These issues indicate a profound lack of control over manufacturing processes and product quality.