FDA 483 - Progenics Pharmaceuticals, Inc. - March 20, 2020

Progenics Pharmaceuticals, Inc. received a Form 483 citing multiple significant deficiencies in its manufacturing operations for AZEDRA (Iobenguane I 131) Injection. The inspection revealed failures in thoroughly investigating out-of-specification results, maintaining adequate quality control unit procedures, and completing annual product reviews. Additional concerns included inadequate facility space, poor material segregation, insufficient computer system controls, and a deficient environmental monitoring program for sterile drug products.