FDA 483 - InvaGen Pharmaceuticals, Inc. - May 25, 2018

Invagen Pharmaceuticals, Inc. in Hauppauge, NY, was inspected and cited for significant deficiencies in quality control and data management. The inspection revealed failures in timely field alert reporting for out-of-specification results and product mix-ups, inadequate investigation of discrepancies and complaints, and non-adherence to stability testing programs. Additionally, the firm experienced a ransomware attack that led to the permanent loss of critical electronic laboratory data due to a lack of secure backups.