FDA 483 - PETNET Solutions, Inc. - July 09, 2021

PETNET Solutions, Inc. in Albany, NY, a pharmaceutical PET drug manufacturer, was cited for significant deficiencies during an FDA inspection. The firm failed to implement appropriate corrective and preventative actions for out-of-specification results, instead invalidating initial OOS results and releasing affected batches. Additionally, the inspection revealed inadequate validation of laboratory analytical methods and a lack of procedures to ensure equipment suitability for its intended purpose, potentially affecting the quality of PET drugs.