FDA 483 - InvaGen Pharmaceuticals, Inc. - February 09, 2026

Invagen Pharmaceuticals, Inc. in Hauppauge, NY, was issued a Form 483 with two observations following an FDA inspection. The firm failed to perform Performance Qualification for serialization and aggregation equipment used in drug product packaging. Additionally, the inspection found that the company did not record and review data generated from its automatic assembling packaging equipment, indicating issues with data accuracy and control.