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

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