FDA 483 - APARNA ORGANICS LIMITED - September 11, 2023

Aparna Organics Limited, an Intermediate API Manufacturer in Chilivalasa, India, received a Form 483 with repeat observations concerning significant quality system deficiencies. The inspection revealed inadequate equipment cleaning, a lack of quality unit oversight, and insufficient controls over electronic GMP data. These issues indicate a moderate level of severity regarding the firm's adherence to good manufacturing practices.