Acme United Corporation
Form 483 issued May 26, 2017 · Brooksville, Florida
- Inspection
- May 22 – May 26, 2017
- Investigator
- Chery A. Causen
- Observations
- 14
- Pages
- 7
- FEI number
- 3012129555
In short: On May 26, 2017, FDA issued a Form 483 with 14 observations to Acme United Corporation in Brooksville, Florida (FEI 3012129555) after an inspection that ran May 22 – May 26, 2017. The investigator was Chery A. Causen. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 02
Towelettes. Excess labeling bearing lot or control…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Chery A. Causen
1 document · 2017
Cites 211.22(a) (responsibilities of quality control unit) 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 211.56(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Acme United Corporation?
FDA listed 14 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Acme United Corporation?
Chery A. Causen is named on this Form 483, for the inspection of May 22 – May 26, 2017. Each investigator has a profile showing what they cite most.
When was Acme United Corporation inspected by FDA?
The inspection ran May 22 – May 26, 2017, and the Form 483 is dated May 26, 2017.
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.