Higley Industries, Inc.
FDA inspection history in Dyersville, Iowa, 2023 to 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2023: one Form 483; 2024: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24One Form 483 and one warning letter, at Dyersville, Iowa.
Cited most
Across all Higley Industries observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.186(b)(9)Master production and control records1
- 21 CFR 211.192Production record review1
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment1
The complete Higley Industries file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Dyersville, Iowa
One warning letter and one Form 483 · 2023 to 2024 · 6 observations
Latest: Warning letter, Feb 22, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-22 | Warning letter Warning letter | Dyersville, Iowa | — | $99 |
| 2023-09-21 | 483 Form 483 | Dyersville, Iowa | 6 | $99 |
Investigators on these documents
FEI number 3002984417 · most recent document Feb 22, 2024
About Higley Industries, Inc.
How many FDA Form 483s has Higley Industries, Inc. received?
FDA Intel has 1 Form 483 on file for Higley Industries, Inc.; the most recent is dated Sep 21, 2023.
When was Higley Industries, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Higley Industries, Inc. is a Form 483 dated Sep 21, 2023, for the site in Dyersville, Iowa.
What did FDA cite at Higley Industries, Inc.?
The regulations cited most in the observations on file for Higley Industries, Inc. are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.186(b)(9) (Master production and control records), 1 time.
Has Higley Industries, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Higley Industries, Inc.; the most recent is dated Feb 22, 2024.