Drug establishmentActive, Registered FY2026FDA warning letter on file
Spartan Chemical Company, Inc.
Spartan Chemical Company, Inc. is an FDA-registered drug establishment (FEI 3001451695) located in Maumee, Ohio. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2025-11-21) 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
Dec 12, 2022 · Voluntary Action Indicated (VAI)
Mar 26, 2021 · Official Action Indicated (OAI)
Dec 9, 2016 · No Action Indicated (NAI)
Dec 12, 2022, 4 observations: Records not made readily available to FDA; Computer control of master formula records; Scientifically sound laboratory controls
Mar 26, 2021, 6 observations: Investigations of discrepancies, failures; Rejecting When Specifications Not Met; Control procedures to monitor and validate performance
Questions
Is Spartan Chemical Company, Inc. registered with the FDA?
Yes. Spartan Chemical Company, Inc. is an FDA-registered drug establishment (FEI 3001451695) in Maumee, Ohio. Its current registration status is Active, Registered FY2026.
Has Spartan Chemical Company, Inc. received an FDA warning letter?
Yes. FDA issued a warning letter to Spartan Chemical Company, Inc.; the most recent is dated Dec 15, 2021 (CGMP/Finished Pharmaceuticals/Adulterated).
What does Spartan Chemical Company, Inc. do?
Spartan Chemical Company, Inc.'s FDA-registered operations are: Manufacturing.
Related facilities
Source: FDA public data · status as of 2026-06-06