Drug establishmentActive, Registered FY2026FDA warning letter on file
Marcus Research Laboratory, Inc.
Marcus Research Laboratory, Inc. is an FDA-registered drug establishment (FEI 1950348) located in Saint Louis, Missouri. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2024-07-12) was classified VAI. 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
Jul 12, 2024 · Voluntary Action Indicated (VAI)
Sep 2, 2022 · Official Action Indicated (OAI)
Sep 2, 2022 · Official Action Indicated (OAI)
May 14, 2021 · Official Action Indicated (OAI)
May 14, 2021 · Official Action Indicated (OAI)
Dec 6, 2019 · Official Action Indicated (OAI)
Dec 6, 2019 · Official Action Indicated (OAI)
Apr 6, 2017 · Voluntary Action Indicated (VAI)
Apr 6, 2017 · Voluntary Action Indicated (VAI)
Jun 20, 2014 · Voluntary Action Indicated (VAI)
Jun 20, 2014 · Voluntary Action Indicated (VAI)
Questions
Is Marcus Research Laboratory, Inc. registered with the FDA?
Yes. Marcus Research Laboratory, Inc. is an FDA-registered drug establishment (FEI 1950348) in Saint Louis, Missouri. Its current registration status is Active, Registered FY2026.
Has Marcus Research Laboratory, Inc. received an FDA warning letter?
Yes. FDA issued a warning letter to Marcus Research Laboratory, Inc.; the most recent is dated Sep 30, 2021 (CGMP/Active Pharmaceutical Ingredient (API)/Adulterated).
What does Marcus Research Laboratory, Inc. do?
Marcus Research Laboratory, Inc.'s FDA-registered operations are: Active pharmaceutical ingredient (API) manufacturing.
Related facilities
Source: FDA public data · status as of 2026-06-06