FDA 483 - Professional Specialties Co Inc - March 02, 2018

An FDA inspection of Professional Specialties Co Inc in Memphis, TN, a manufacturer and repackager of medical devices, identified significant quality system deficiencies. The firm failed to adequately control nonconforming products, document corrective actions, and establish proper complaint handling procedures. Key issues also included the absence of required Device Master Records and Device History Records, indicating a broad non-compliance with medical device regulations.