Cincinnati Sub-Zero Products Inc – FDA Warning Letter, Dec 14, 2009

On October 15, 2009, an FDA inspection of Cincinnati Sub-Zero Products, Inc. revealed that their medical devices, including Blanketrol II/III and Hemotherm, were adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a))**: Issues included not investigating nonconformities (e.g., sterile packaging breaches, debris in seals, reservoir elbow leaks), not verifying CAPA effectiveness, and lacking evidence of field action completion. 2. **Failure to analyze quality data (21 CFR 820.100(a)(1))**: The firm did not analyze supplier performance data or accurately trend complaint data, omitting relevant complaints from analyses. 3. **Inadequate complaint handling (21 CFR 820.198(c))**: Six of 40 complaints were not adequately investigated, lacking root cause determination, testing evidence, or proper follow-up for product returns. An RMA was not opened as a complaint. 4. **Failure to validate device design, including software (21 CFR 820.30(g))**: Software for Blanketrol II lacked