FDA 483 - Aurore Pharmaceuticals Private Limited (Unit I) - May 27, 2024

Aurore Pharmaceutical Pvt Ltd in Hyderabad, India, received a Form 483 with five observations related to significant deficiencies in their Active Pharmaceutical Ingredient (API) manufacturing operations. The inspection revealed issues with equipment cleaning and maintenance, inadequate production and process controls, insufficient investigation of failures, poor facility maintenance, and a quality control unit failing to ensure product specifications. These findings indicate a moderate level of severity concerning GMP compliance.