FDA WARNING_LETTER - TFS Manufacturing Pty Ltd. - August 20, 2015

On December 21, 2015, the FDA issued a Warning Letter to TFS Manufacturing Pty Ltd. following an inspection from August 17-20, 2015, in Allenby Gardens, Australia. The inspection revealed that the firm's sterile mesh implant systems are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Design Verification (21 CFR 820.30(f)):** Failure to establish and maintain procedures for verifying device design and documenting results in Design History Files (DHF). For example, no design verification protocols or acceptance criteria for Polypropylene Mesh Implants, and the July 3, 2015, report lacked test dates, personnel names, and equipment calibration status. The firm's response was inadequate as it indicated informal documentation and retrospective review, and an addendum still lacked acceptance criteria. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Failure to establish and maintain CAPA procedures, specifically lacking requirements for data analysis, statistical methodology, and verification/validation of effectiveness. CAPA 008 lacked investigation results for a sterile packaging process change