FDA 483 - InvaGen Pharmaceuticals, Inc.

Invagen Pharmaceuticals, Inc. in Hauppauge, NY, a drug manufacturer, was cited for three observations during an FDA inspection in March 2017. The inspection revealed significant issues with data integrity, including failures in maintaining backup files, inadequate computer system controls allowing unauthorized data deletion, and insufficient record retention practices for drug product control and labeling. These findings indicate a lack of robust controls over electronic data and physical records, which are critical for ensuring product quality and regulatory compliance.