FDA 483 - Petnet Solutions Inc - January 20, 2023

An FDA inspection of Petnet Solutions Inc in Fort Lauderdale, FL, revealed significant deficiencies in quality control and facility contamination prevention. The firm failed to take appropriate corrective actions for out-of-specification endotoxin results and conducted retesting without proper invalidation. Additionally, the facility's environmental monitoring program was found inadequate, posing a risk of product contamination.