FacilityLedger

Device establishmentActive, RegisteredFDA warning letter on file

Longhorn Vaccines and Diagnostics LLC

Longhorn Vaccines and Diagnostics LLC is an FDA-registered device establishment (FEI 3011818318) located in Bethesda, Maryland. The facility is active, registered. Its most recent FDA inspection on record (2025-10-30) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Feb 26, 2026
CGMP/QSR/Medical Devices/Adulterated
Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (1)

Jun 3, 2020 Class II
The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain system
OngoingView source data ›

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
3011818318
Address
7272 Wisconsin Avenue, Bethesda, Maryland
Establishment type
Device establishment
Products / operations
Microbiology, Develop Specifications But Do Not Manufacture At This Facility, Complaint File Establishment per 21 CFR 820.198
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Oct 30, 2025 · Official Action Indicated (OAI)
Form 483 observations
Oct 30, 2025, 2 observations: Lack of or inadequate organizational structure; Design history file

FDA record timeline

Warning letter
CGMP/QSR/Medical Devices/Adulterated
Source ›
FDA inspection
OAI classification
Form 483
2 observations
Recall
Class II — The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain system
Source ›

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is Longhorn Vaccines and Diagnostics LLC registered with the FDA?

Yes. Longhorn Vaccines and Diagnostics LLC is an FDA-registered device establishment (FEI 3011818318) in Bethesda, Maryland. Its current registration status is Active, Registered.

Has Longhorn Vaccines and Diagnostics LLC received an FDA warning letter?

Yes. FDA issued a warning letter to Longhorn Vaccines and Diagnostics LLC; the most recent is dated Feb 26, 2026 (CGMP/QSR/Medical Devices/Adulterated).

What does Longhorn Vaccines and Diagnostics LLC do?

Longhorn Vaccines and Diagnostics LLC's FDA-registered operations are: Microbiology, Develop Specifications But Do Not Manufacture At This Facility, Complaint File Establishment per 21 CFR 820.198.

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Source: FDA public data · status as of 2026-08-22

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