FDA 483 - Aktinos Pharma Private Limited - Unit II - December 12, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 404b0eaf-37de-4dee-bf35-ce0d82f00e0e