FDA 483 - Cosmed of New Jersey - April 24, 2026

An FDA inspection of Lynx Medical of NJ LLC in Franklin, NJ, a contract sterilizer of medical devices, revealed significant deficiencies in its quality system. The firm failed to adequately document and control nonconforming products, often bypassing formal evaluation and disposition processes. Additionally, its risk management procedures for product realization were found to be inadequately implemented, potentially compromising patient safety.