Dishman Carbogen Amcis Limited – FDA 483, Mar 7, 2024

An FDA inspection of Dishman Carbogen Amcis Limited, an API manufacturer in Sanand (Bavla) Ahmedabad Gujarat, revealed four observations related to significant deficiencies in their manufacturing processes. The issues included inadequate equipment maintenance, incomplete batch records, insufficient GMP training for employees, and a lack of detailed procedures for the storage and handling of temperature-sensitive components. These findings indicate a need for improved procedural controls and documentation to ensure product quality and compliance.