FDA 483 - Petnet Solutions, Inc. - September 19, 2025

Petnet Solutions, Inc. in Hackensack, NJ, was cited for two observations during an FDA inspection from September 15-19, 2025. The firm failed to ensure adequate facilities for contamination prevention during aseptic operations and did not conduct proper investigations or corrective actions for recurring product failures and out-of-tolerance equipment. These issues indicate significant concerns regarding product quality and manufacturing control.