FDA 483 - Prince Sterilization Services, LLC - September 26, 2022

Prince Sterilization Services, Llc in Fairfield, NJ, was cited for significant deficiencies in their sterilization and packaging processes during an FDA inspection. The firm failed to adhere to validated sterilization procedures, resulting in incorrect vial loading, and lacked adequate monitoring to ensure the consistent integrity of their sterile packaging. These issues indicate a serious lack of control over critical manufacturing processes for sterile products.