FDA 483 - Aktinos Pharma Private Limited - Unit II - October 14, 2022

Aktinos Pharma Private Limited. Unit-II, an Active Pharmaceutical Ingredient (API) manufacturer in Visakhapatnam, India, was cited for significant deficiencies across multiple quality systems. The inspection revealed issues with inadequate investigations, insufficient written procedures, lack of proper employee training, poorly maintained equipment, and failures in following production and process control procedures. These observations indicate a general lack of adherence to current Good Manufacturing Practices (cGMP).