FDA 483 - North American Medical Corp. (NAM) - December 09, 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.