North American Medical Corp. (NAM) – FDA 483, Dec 9, 2022

An FDA inspection of North American Medical Corp. (NAM) in Marietta, GA, identified significant deficiencies in their quality system related to the SPINA System with cervical/Accu-SPINA model 21. Observations included a lack of established process control procedures for PFMEA documents, inadequate training procedures and records, and insufficient documentation of rework activities in device history records. These findings indicate a need for improved quality system controls to ensure product quality and regulatory compliance.