FDA 483 - Azico Biophore India Private Limited

An FDA inspection of Azico Biophore India Private Limited, an Active Pharmaceutical Ingredient manufacturer in Parawada, India, from November 30 to December 7, 2015, revealed significant deficiencies. The firm was cited for inadequate analytical method validation, insufficient investigation of Out of Specification results, and poor documentation practices in batch production records. These observations indicate a lack of robust quality control and assurance systems.