FDA 483 - Aktinos Pharma Private Limited - Unit II - December 12, 2025

An FDA inspection of Aktinos Pharma Private Limited - Unit II, an API manufacturer in Anakapalli, India, revealed significant deficiencies in quality control and equipment maintenance. The firm's Quality Unit failed to identify out-of-specification results during batch record review, leading to the release of non-conforming intermediate batches. Additionally, manufacturing equipment was not maintained in a clean condition or good state of repair, including a cracked vessel and equipment with residue and pitting.