FDA 483 - PETNET Solutions, Inc. - February 03, 2026

PETNET Solutions, Inc. in Cincinnati, OH, a manufacturer of PET drug products, received a Form 483 with five observations related to significant quality control deficiencies. These issues include inadequate stability studies, lack of identity testing for inactive ingredients, unverified compendial test procedures, insufficient cleaning validation for manufacturing equipment, and failure to properly investigate nonconforming batches. The observations indicate a systemic breakdown in ensuring product quality and adherence to established procedures.