FDA-Inspected Site

Acme United Corporation

3 FDA inspections are on record for Acme United Corporation in Brooksville, United States.

483· Form 483 issued

Brooksville, United States · Last updated July 9, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-03-28.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 Mar 2025 – 28 Mar 2025Human DrugsWLView 483 →
25 Feb 2019 – 8 Mar 2019Human Drugs483View 483 →
22 May 2017 – 26 May 2017Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

28 Mar 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Nicole E Knowlton

28 Mar 2025
21 CFR 211.105(a)

Identification of containers, lines, equipment

Cited by Nicole E Knowlton

28 Mar 2025
21 CFR 211.165(b)

Microbiological testing

Cited by Nicole E Knowlton

28 Mar 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Nicole E Knowlton

28 Mar 2025
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Nicole E Knowlton

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.68(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.105(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(d)Cited across public-safe Form 483 observations1x
21 CFR 211.137(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(c)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Acme United Corporation's 3 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat