Vincent Medical (Dong Guan) Manufacturing Co., Ltd. – FDA Warning Letter, May 30, 2013

An FDA inspection of Vincent Medical (Don Guan) Manufacturing Company, Limited in China, conducted from May 27-30, 2013, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803). The firm manufactures breathing circuits and sterile fluid management injection systems, which are deemed adulterated and misbranded. The firm's initial response to the FDA 483 was not reviewed due to late submission. Key deficiencies include the failure to establish and maintain adequate procedures for corrective and preventive actions (CAPA), process validation, design review, design transfer to production, complaint handling, and quality audits. Specifically, the firm lacked proper documentation for CAPA investigations, process validation records, design review participants and results, pilot run records, and timely complaint processing. Additionally, the firm failed to document acceptance activities, ensure calibration procedures included remedial actions for out-of-tolerance equipment, and control labeling/packaging to prevent mix-ups. A critical violation was the failure to adequately develop and implement written MDR procedures, including definitions for reportable events and submission addresses. The FDA requires the firm to provide a written response within fifteen business days detailing specific corrective actions, preventative measures, supporting documentation, and a timetable for implementation. Failure to correct these violations will impact premarket approval for Class III devices, issuance of Certificates to Foreign Governments, and potential federal contract awards. The letter emphasizes that these issues may indicate broader problems within the firm's quality management systems.