# FDA WARNING_LETTER - Cincinnati Sub-Zero Products Inc - December 14, 2009

Source: https://www.keypedia.com/records/warning_letter/cincinnati-sub-zero-products-inc/071c9077-5c4b-4b9a-879b-124f04999861

> FDA WARNING_LETTER for Cincinnati Sub-Zero Products Inc on December 14, 2009. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cincinnati Sub-Zero Products Inc
- Inspection Date: 2009-12-14
- Product Type: Food
- Office Name: Cincinnati District Office
- Summary: 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

## Related Officers

- [Mark E. Parmon](https://www.keypedia.com/people/mark-e-parmon/acada198-6b46-47de-a605-51cec0af2d15)
- [Teresa C. Thompson](https://www.keypedia.com/people/teresa-c-thompson/b41b98e5-2a7c-4f19-923b-058a197a8fd4)

Company: https://www.keypedia.com/companies/cincinnati-sub-zero-products-inc/73fbfb05-536e-4394-9ddd-410c67807f5e

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22