Drug establishmentActive, Registered FY2026FDA warning letter on file

Missouri Analytical Laboratories, Inc.

Missouri Analytical Laboratories, Inc. is an FDA-registered drug establishment (FEI 1946524) located in Saint Louis, Missouri. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2022-09-02) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Sep 30, 2021

CGMP/Active Pharmaceutical Ingredient (API)/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

1946524

Address

1820 Delmar Blvd., Saint Louis, Missouri

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 2, 2022 · Voluntary Action Indicated (VAI)
Sep 2, 2022 · Voluntary Action Indicated (VAI)
May 19, 2021 · Official Action Indicated (OAI)
Apr 6, 2017 · Voluntary Action Indicated (VAI)
Apr 6, 2017 · Voluntary Action Indicated (VAI)
Apr 16, 2015 · No Action Indicated (NAI)
Apr 16, 2015 · No Action Indicated (NAI)
Dec 7, 2011 · No Action Indicated (NAI)
Dec 7, 2011 · No Action Indicated (NAI)
Jan 21, 2010 · No Action Indicated (NAI)
Jan 21, 2010 · No Action Indicated (NAI)

Form 483 observations

May 19, 2021, 5 observations: Training , Education , Experience overall; Computer control of master formula records; Procedures not in writing, fully followed

Questions

Is Missouri Analytical Laboratories, Inc. registered with the FDA?

Yes. Missouri Analytical Laboratories, Inc. is an FDA-registered drug establishment (FEI 1946524) in Saint Louis, Missouri. Its current registration status is Active, Registered FY2026.

Has Missouri Analytical Laboratories, Inc. received an FDA warning letter?

Yes. FDA issued a warning letter to Missouri Analytical Laboratories, Inc.; the most recent is dated Sep 30, 2021 (CGMP/Active Pharmaceutical Ingredient (API)/Adulterated).

What does Missouri Analytical Laboratories, Inc. do?

Missouri Analytical Laboratories, Inc.'s FDA-registered operations are: Analytical testing.

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