Acme United Corporation
FDA inspection history across 2 sites, 2017 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2017: one Form 483; 2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Brooksville, Florida.
- 2017The longest 483 on file: 14 observations over 7 pages at Brooksville, Florida.
- 2025One warning letter and one Form 483, at Shelton, Connecticut and Brooksville, Florida.
Cited most
Across all Acme United observations on file
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment3
- 21 CFR 211.165(b)Testing and release for distribution2
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.103Calculation of yield1
The complete Acme United file.
All 3 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
Brooksville, Florida
Two Form 483s · 2017 to 2025 · 21 observations
Latest: Form 483, Mar 28, 2025 →Shelton, Connecticut
One warning letter · 2025
Latest: Warning letter, Oct 10, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-10-10 | Warning letter Warning letter | Shelton, Connecticut | — | $99 |
| 2025-03-28 | 483 Form 483 | Brooksville, Florida | 7 | $99 |
| 2017-05-26 | 483 Form 483 | Brooksville, Florida | 14 | $99 |
Investigators on these documents
FEI number 3012129555 · most recent document Oct 10, 2025
About Acme United Corporation
How many FDA Form 483s has Acme United Corporation received?
FDA Intel has 2 Form 483s on file for Acme United Corporation; the most recent is dated Mar 28, 2025.
When was Acme United Corporation last inspected by FDA?
The most recent FDA inspection document on file for Acme United Corporation is a Form 483 dated Mar 28, 2025, for the site in Brooksville, Florida.
What did FDA cite at Acme United Corporation?
The regulations cited most in the observations on file for Acme United Corporation are 21 CFR 211.68(a) (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.165(b) (Testing and release for distribution), 2 times; 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times.
Has Acme United Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Acme United Corporation; the most recent is dated Oct 10, 2025.