Acme United Corporation
Form 483 issued March 28, 2025 · Brooksville, Florida
- Inspection
- Mar 18 – Mar 28, 2025
- Investigator
- Nicole E. Knowlton
- Observations
- 7
- Pages
- 16
- FEI number
- 3012129555
In short: On March 28, 2025, FDA issued a Form 483 with 7 observations to Acme United Corporation in Brooksville, Florida (FEI 3012129555) after an inspection that ran Mar 18 – Mar 28, 2025. The investigator was Nicole E. Knowlton. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review whether or not the batch…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmAcme United Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Acme United Corporation?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Acme United Corporation?
Nicole E. Knowlton is named on this Form 483, for the inspection of Mar 18 – Mar 28, 2025. Each investigator has a profile showing what they cite most.
When was Acme United Corporation inspected by FDA?
The inspection ran Mar 18 – Mar 28, 2025, and the Form 483 is dated March 28, 2025.
How do I get the full Form 483 for Acme United Corporation?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.