Drug establishmentActive, Registered FY2026FDA warning letter on file

Bell International Laboratories, Inc

Bell International Laboratories, Inc is an FDA-registered drug establishment (FEI 3005574978) located in Eagan, Minnesota. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2025-06-12) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Feb 15, 2024

CGMP/Finished Pharmaceuticals/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

3005574978

Address

2950 Lexington Avenue S Ste 100, Eagan, Minnesota

Establishment type

Drug establishment

Products / operations

Manufacturing

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Jun 12, 2025 · Voluntary Action Indicated (VAI)
Sep 19, 2023 · Official Action Indicated (OAI)
Jun 22, 2017 · Voluntary Action Indicated (VAI)
Jan 29, 2015 · Voluntary Action Indicated (VAI)
May 14, 2014 · No Action Indicated (NAI)
Jun 26, 2013 · Voluntary Action Indicated (VAI)
Jun 26, 2013 · Voluntary Action Indicated (VAI)
Nov 9, 2010 · Voluntary Action Indicated (VAI)
Jul 7, 2009 · No Action Indicated (NAI)
Jul 7, 2009 · Voluntary Action Indicated (VAI)
Jul 7, 2009 · Voluntary Action Indicated (VAI)

Form 483 observations

Jun 22, 2017, 5 observations: Testing and release for distribution; Rejecting When Specifications Not Met; Component written specification
Jan 29, 2015, 4 observations: Rejecting When Specifications Not Met; Items to cover on annual reviews; Control procedures to monitor and validate performance
Jul 7, 2009, 7 observations: Complete test data included in records; Scientifically sound laboratory controls; Equipment Design, Size and Location

Questions

Is Bell International Laboratories, Inc registered with the FDA?

Yes. Bell International Laboratories, Inc is an FDA-registered drug establishment (FEI 3005574978) in Eagan, Minnesota. Its current registration status is Active, Registered FY2026.

Has Bell International Laboratories, Inc received an FDA warning letter?

Yes. FDA issued a warning letter to Bell International Laboratories, Inc; the most recent is dated Feb 15, 2024 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Bell International Laboratories, Inc do?

Bell International Laboratories, Inc's FDA-registered operations are: Manufacturing.

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