Drug establishmentActive, Registered FY2026FDA warning letter on file

ABR Laboratory LLC

ABR Laboratory LLC is an FDA-registered drug establishment (FEI 3020570829) located in Hollywood, Florida. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2024-09-13) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Feb 10, 2025

CGMP/Finished Pharmaceutical/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.

Establishment record

FEI Number

3020570829

Address

450 N Park Rd Ste 303, Hollywood, Florida

Establishment type

Drug establishment

Products / operations

Analytical testing

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Sep 13, 2024 · Official Action Indicated (OAI)

Form 483 observations

Sep 13, 2024, 3 observations: Scientifically sound laboratory controls; Procedures not in writing, fully followed; Test methods

Questions

Is ABR Laboratory LLC registered with the FDA?

Yes. ABR Laboratory LLC is an FDA-registered drug establishment (FEI 3020570829) in Hollywood, Florida. Its current registration status is Active, Registered FY2026.

Has ABR Laboratory LLC received an FDA warning letter?

Yes. FDA issued a warning letter to ABR Laboratory LLC; the most recent is dated Feb 10, 2025 (CGMP/Finished Pharmaceutical/Adulterated).

What does ABR Laboratory LLC do?

ABR Laboratory LLC's FDA-registered operations are: Analytical testing.

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Source: FDA public data · status as of 2026-06-06