FDA 483 - Superior Surgical, Llc - March 10, 2022

An FDA inspection of Superior Surgical, Llc, a medical device repackager/relabeler in Pottstown, PA, revealed significant deficiencies in its quality management system. The firm failed to conduct management reviews, perform internal quality audits, document corrective and preventive actions, and adequately establish records for acceptable suppliers. These findings indicate a systemic breakdown in maintaining a compliant quality system.