Drug establishmentActive, Registered FY2026FDA warning letter on file

Microbiological Testing & Consulting, LLC

Microbiological Testing & Consulting, LLC is an FDA-registered drug establishment (FEI 3003875820) located in Alsip, Illinois. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2025-09-16) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Mar 16, 2026

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

3003875820

Address

5661 W 120th St, Alsip, Illinois

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 16, 2025 · Official Action Indicated (OAI)
Mar 8, 2018 · Voluntary Action Indicated (VAI)
Jul 27, 2016 · Voluntary Action Indicated (VAI)
Jun 21, 2011 · Voluntary Action Indicated (VAI)
Jun 21, 2011 · Voluntary Action Indicated (VAI)
Feb 24, 2010 · Voluntary Action Indicated (VAI)

Form 483 observations

Sep 16, 2025, 5 observations: Microbiological testing; Procedures not in writing, fully followed; GMP Training Frequency
Mar 8, 2018, 5 observations: Procedures not in writing, fully followed; Microbiological testing; Scientifically sound laboratory controls
Jul 27, 2016, 5 observations: Scientifically sound laboratory controls; Establishment of calibration procedures; Microbiological testing
Jun 21, 2011, 5 observations: Equipment Design, Size and Location; Complete test data included in records; Microbiological testing
Feb 24, 2010, 3 observations: Test methods; Scientifically sound laboratory controls; Following/documenting laboratory controls

Questions

Is Microbiological Testing & Consulting, LLC registered with the FDA?

Yes. Microbiological Testing & Consulting, LLC is an FDA-registered drug establishment (FEI 3003875820) in Alsip, Illinois. Its current registration status is Active, Registered FY2026.

Has Microbiological Testing & Consulting, LLC received an FDA warning letter?

Yes. FDA issued a warning letter to Microbiological Testing & Consulting, LLC; the most recent is dated Mar 16, 2026 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Microbiological Testing & Consulting, LLC do?

Microbiological Testing & Consulting, LLC's FDA-registered operations are: Analytical testing.

Related facilities

Accupack Midwest Chemco Corporation Aerosol and Liquid Packaging, Inc.Fareva Morton Grove, Inc.DENTAL TECHNOLOGIES, INC.Sunstar Americas, Inc.

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