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 3010982075.
Violations0
Issue DateApr 17, 2024
Product TypeDevices
StatusOpen
Letter Details
Firm
Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs
Location
United States
FEI Number
3010982075
Country
United States
Issue Date
April 17, 2024
Issuing Office
Center for Devices and Radiological Health
Product Type
Devices
Status
Open
Summary
Based on limited metadata available, Pinnacle Labs of Tennessee, LLC (operating as Pinnacle BioLabs) received an FDA Warning Letter on April 17, 2024, regarding medical devices. Without access to the full letter text or subject line, the specific nature of the violations cannot be determined from the metadata provided. The warning falls under FDA's device regulatory authority, though the specific issuing office and exact violation count are not available in this summary record.
Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs FDA Warning Letter, April 17, 2024