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
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
Inspection history
Mar 8, 2018 · Voluntary Action Indicated (VAI)
Jul 27, 2016 · Voluntary Action Indicated (VAI)
Jun 21, 2011 · Voluntary Action Indicated (VAI)
Feb 24, 2010 · Voluntary Action Indicated (VAI)
Mar 8, 2018, 5 observations: Scientifically sound laboratory controls; Microbiological testing; Complete test data included in records
Jul 27, 2016, 5 observations: Microbiological testing; Calibration - at intervals, written program, remedial action; Complete test data included in records
Jun 21, 2011, 5 observations: Scientifically sound laboratory controls; Complete test data included in records; Microbiological testing
Feb 24, 2010, 3 observations: Scientifically sound laboratory controls; Following/documenting laboratory controls; Test methods
FDA record timeline
Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.
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
Source: FDA public data · status as of 2026-08-22