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Warning Letters
Longhorn Vaccines and Diagnostics LLC
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Longhorn Vaccines and Diagnostics LLC
Warning Letter
Open
7272 Wisconsin Avenue, Ste 900 Bethesda , MD 20814 United States
Issued Feb 26, 2026
Center for Devices and Radiological Health
Watch Company
View Letter
Source: FDA, published letter.
FDA published this warning letter; View Letter opens FDA's copy.
Violations
31
Issue Date
Feb 26, 2026
Product Type
Medical Devices
Status
Open
Overview
Violations
31
Related Form 483s
1
Related Inspections
0
Letter Details
Firm
Longhorn Vaccines and Diagnostics LLC
Location
7272 Wisconsin Avenue, Ste 900 Bethesda , MD 20814 United States
FEI Number
N/A
Country
United States
Issue Date
February 26, 2026
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Subject
CGMP/QSR/Medical Devices/Adulterated
See the 31 Violations
Longhorn Vaccines and Diagnostics LLC FDA Warning Letter, February 26, 2026