FDA 483 - Praxis Powder Technology, Inc. - July 29, 2022

An FDA inspection of Praxis Powder Technology, Inc. in Queensbury, NY, a contract manufacturer of medical implants, revealed significant deficiencies in their corrective and preventive action (CAPA) system. Specifically, the firm failed to adequately document investigations, sampling plans, risk assessments, and preventative measures related to product discoloration and potential cross-contamination issues. These findings indicate a serious breakdown in quality system controls that could impact product quality and patient safety.