Drug establishmentActive, Registered FY2026FDA warning letter on file

Liebel-Flarsheim Company LLC

Liebel-Flarsheim Company LLC is an FDA-registered drug establishment (FEI 1028892) located in , North Carolina. The facility is active, registered for FY2026. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Oct 17, 2025
CGMP/Finished Pharmaceuticals/Adulterated

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
1028892
Address
8800 Durant Road, , North Carolina
Establishment type
Drug establishment
Products / operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Registration status
Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file
None on file
Form 483 observations
None on file

FDA publishes only a subset of inspection records and Form 483s, so "None on file" is not a guarantee of a clean inspection history.

Questions

Is Liebel-Flarsheim Company LLC registered with the FDA?

Yes. Liebel-Flarsheim Company LLC is an FDA-registered drug establishment (FEI 1028892) in , North Carolina. Its current registration status is Active, Registered FY2026.

Has Liebel-Flarsheim Company LLC received an FDA warning letter?

Yes. FDA issued a warning letter to Liebel-Flarsheim Company LLC; the most recent is dated Oct 17, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Liebel-Flarsheim Company LLC do?

Liebel-Flarsheim Company LLC's FDA-registered operations are: ANALYSIS; LABEL; MANUFACTURE; PACK.

Related facilities

Source: FDA public data · status as of 2026-06-01

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