FDA WARNING_LETTER - Surgical Implant Generation Network - August 12, 2008

During a July-August 2008 inspection, the FDA determined that SIGN IM Nail and SIGN Fin Nail devices manufactured by the firm were adulterated and misbranded. The devices were adulterated under 21 U.S.C. 351(h) due to non-conformance with Current Good Manufacturing Practice (CGMP) requirements set forth in the Quality System (QS) regulation (21 CFR Part 820). They were misbranded under 21 U.S.C. 352(t)(2) for failing to furnish required material or information per 21 U.S.C. 360i and the Medical Device Reporting (MDR) regulation (21 CFR Part 803).

Violations included: 1. **Failure to establish and maintain design control procedures (21 CFR 820.30(a)):** The firm did not complete required forms (DDP-001, DIF-001, DRF-001) for the SIGN Fin Nail design. 2. **Failure to establish and maintain procedures for validating device design and including risk analysis (21 CFR 820.30(g)):** No risk analysis was conducted for the SIGN Fin Nail, even after significant design changes and new indications for use. 3. **Failure to report serious injuries within 30 days (2