Drug establishmentActive, Registered FY2026FDA warning letter on file
Chemco Corporation
Chemco Corporation is an FDA-registered drug establishment (FEI 1042599) located in Hialeah, Florida. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2025-08-22) 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
Feb 12, 2019 · Official Action Indicated (OAI)
Feb 12, 2019 · Official Action Indicated (OAI)
Mar 6, 2017 · Voluntary Action Indicated (VAI)
Feb 12, 2019, 4 observations: Written complaint record to be maintained at facility; Testing and release for distribution; Accurate reproduction included
Mar 6, 2017, 6 observations: Investigations of discrepancies, failures; Testing and release for distribution; Written records kept in individual logs
Questions
Is Chemco Corporation registered with the FDA?
Yes. Chemco Corporation is an FDA-registered drug establishment (FEI 1042599) in Hialeah, Florida. Its current registration status is Active, Registered FY2026.
Has Chemco Corporation received an FDA warning letter?
Yes. FDA issued a warning letter to Chemco Corporation; the most recent is dated Apr 7, 2026 (Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated).
What does Chemco Corporation do?
Chemco Corporation's FDA-registered operations are: Manufacturing.
Related facilities
Source: FDA public data · status as of 2026-06-06