FDA 483 - Aarti Pharmalabs Limited - February 20, 2020

Aarti Industries Limited, an API manufacturer in Palghar, India, was cited for four observations during an FDA inspection. The inspection revealed issues including insecure storage of quality control samples, incomplete investigations into out-of-specification results, unapproved raw material dispensing and collection bags, and poor documentation practices in sample receiving logs. These deficiencies indicate a lack of adherence to established quality standards and procedures.