# FDA WARNING_LETTER - Augustine Temperature Management, LLC - September 19, 2023

Source: https://www.keypedia.com/records/warning_letter/augustine-temperature-management-llc/71655304-4222-4f52-8c8e-4233ee124497

> FDA WARNING_LETTER for Augustine Temperature Management, LLC on September 19, 2023. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Augustine Temperature Management, LLC
- Inspection Date: 2023-09-19
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On March 21, 2024, the FDA issued a Warning Letter to a manufacturer of Class II patient warming devices, including the HotDog Temperature Management System, following an inspection from September 6-19, 2023. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act, leading to the devices being deemed misbranded and adulterated.

Key violations include:
1.  **Failure to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17).** Deficiencies in the "Vigilance and MDR Reporting Procedure" (Doc# D1041, Rev. N) include omitting critical definitions (e.g., "become aware," "serious injury"), combining regulatory language in a way that could lead to incomplete reporting, and lacking instructions for timely event evaluation and complete report transmission (e.g., FDA 3500A form, follow-up reports, electronic submission). The procedure also failed to describe documentation and record-keeping requirements for MDR event files and decision-making processes.
2.  **Failure to submit an MDR report within 30 days for a serious injury (21 CFR 803.50(a)(1)).** The firm failed to report a second-degree burn requiring debridement and skin grafting, which occurred in December 2020, despite becoming

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## Related Officers

- [Director](https://www.keypedia.com/people/blake-bevill/7ed0dcde-28a7-452b-870d-6e085580abde)
- [Bram D. Zuckerman](https://www.keypedia.com/people/bram-d-zuckerman/f1db0188-ca91-4c3a-828d-f3c6f7450e54)

Company: https://www.keypedia.com/companies/augustine-temperature-management-llc/2d889e67-0742-4b94-a656-d2c2f51ed7e4

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7