FDA 483 - Annora Pharma Private Limited - January 20, 2023

An FDA inspection of Annora Pharma Private Limited in Hyderabad, India, from January 16-20, 2023, revealed significant deficiencies in employee training. The firm failed to provide adequate training to personnel on the specific operations they perform and on critical written procedures required by current good manufacturing practice regulations. This included a lack of training for key staff on Quality Unit responsibilities, change control, data integrity, and various quality management SOPs.