Drug establishmentActive, Registered FY2026FDA warning letter on file
AACE PHARMACEUTICALS, INC.
AACE PHARMACEUTICALS, INC. is an FDA-registered drug establishment (FEI 3013433273) located in , New Jersey. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2024-11-22) 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
Aug 10, 2020 · Voluntary Action Indicated (VAI)
Aug 10, 2020, 3 observations: Following/documenting laboratory controls; Complete Test Data; Equipment construction - reactive surfaces
FDA record timeline
Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.
Questions
Is AACE PHARMACEUTICALS, INC. registered with the FDA?
Yes. AACE PHARMACEUTICALS, INC. is an FDA-registered drug establishment (FEI 3013433273) in , New Jersey. Its current registration status is Active, Registered FY2026.
Has AACE PHARMACEUTICALS, INC. received an FDA warning letter?
Yes. FDA issued a warning letter to AACE PHARMACEUTICALS, INC.; the most recent is dated May 13, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).
What does AACE PHARMACEUTICALS, INC. do?
AACE PHARMACEUTICALS, INC.'s FDA-registered operations are: Analytical testing, Labeling, Manufacturing, Packaging.
Related facilities
Source: FDA public data · status as of 2026-08-22