FDA 483 - Professional Specialties Co Inc - October 21, 2022

An FDA inspection of Professional Specialties Co Inc in Memphis, TN, a manufacturer/repackager/relabeler of devices, revealed significant deficiencies in their quality system. The firm failed to properly document rework activities, conduct internal quality audits, maintain records of management reviews, and ensure complete personnel training records. These issues indicate a systemic failure to implement established procedures.