Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005857264.
Violations0
Issue DateMar 21, 2024
Product TypeDevices
StatusOpen
Letter Details
Firm
Augustine Temperature Management, LLC
Location
United States
FEI Number
3005857264
Country
United States
Issue Date
March 21, 2024
Issuing Office
Center for Devices and Radiological Health
Product Type
Devices
Status
Open
Summary
Based on limited metadata, this FDA Warning Letter issued to Augustine Temperature Management, LLC on March 21, 2024, involves medical devices. Without access to the full letter text or detailed subject information, the specific nature of the violations cannot be determined from the available metadata. The warning falls under FDA's device regulation authority, though the issuing office is not specified. To understand the precise regulatory concerns and required corrective actions, the complete warning letter would need to be reviewed.
Augustine Temperature Management, LLC FDA Warning Letter, March 21, 2024