Drug establishmentActive, Registered FY2026FDA warning letter on file
Higley Industries, Inc.
Higley Industries, Inc. is an FDA-registered drug establishment (FEI 3002984417) located in Dyersville, Iowa. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2025-09-12) 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
Sep 21, 2023 · Official Action Indicated (OAI)
May 29, 2013 · No Action Indicated (NAI)
Questions
Is Higley Industries, Inc. registered with the FDA?
Yes. Higley Industries, Inc. is an FDA-registered drug establishment (FEI 3002984417) in Dyersville, Iowa. Its current registration status is Active, Registered FY2026.
Has Higley Industries, Inc. received an FDA warning letter?
Yes. FDA issued a warning letter to Higley Industries, Inc.; the most recent is dated Feb 22, 2024 (CGMP/Finished Pharmaceuticals/Adulterated).
What does Higley Industries, Inc. do?
Higley Industries, Inc.'s FDA-registered operations are: Manufacturing.
Related facilities
Source: FDA public data · status as of 2026-06-06