Cook Group Inc. – FDA Warning Letter, Apr 19, 2011

On April 4-19, 2011, an FDA inspection of Cook Endoscopy in Winston-Salem, NC, revealed that their Cholangioscopy Access Balloon/DPOC and other gastroenterological/endoscopic devices were adulterated. The manufacturing, packing, storage, or installation methods did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: CAPAs were ineffective or untimely. For example, CAPA #10-16 for the Cholangioscopy Access Balloon (DPOC), linked to patient deaths and serious injuries from air embolism and perforation, lacked thorough investigation and timely corrective actions. The firm voluntarily withdrew its 510(k) for this device. Other CAPAs (e.g., #10-14, #08-02, #09-10) showed late adverse event reporting and lack of preventive actions. 2. **Inadequate design verification (21 CFR 820.30(f))**: Design input for the Cholangioscopy Access Balloon (Project 24001) regarding stone removal was not verified. 3. **Inadequate risk analysis (21 CFR 820.30(g))**: Known and