InvaGen Pharmaceuticals, Inc. – FDA EIR, May 25, 2018

The FDA conducted a routine Good Manufacturing Practice (GMP) surveillance and post-approval inspection of InvaGen Pharmaceuticals, Inc. in Hauppauge, NY, from May 9 to May 25, 2018. The inspection covered the manufacturing of non-sterile generic prescription drugs, including Fenofibrate capsules and Amlodipine Besylate and Valsartan tablets, under the regulatory framework of FDA Compliance Programs and the Federal Food, Drug, and Cosmetic Act. It also included follow-ups to prior inspections and complaint investigations. The inspection resulted in a six-item Form FDA 483 listing significant observations. Primary issues included InvaGen’s failure to submit NDA-Field Alert Reports within three working days for distributed batches not meeting specifications or for products mistakenly identified as another. The firm also failed to thoroughly investigate unexplained discrepancies, did not consistently follow its written stability testing program, and lacked scientifically sound specifications in its laboratory controls. A recurring violation was the failure to maintain backup files for data entered into computer systems. Following the inspection, management was required to submit a comprehensive written response to the FDA’s observations within 15 working days, which they agreed to do.