Custom Wire Technologies Inc
Form 483 issued February 18, 2022 · Port Washington, Wisconsin
- Inspection
- Feb 10 – Feb 18, 2022
- Investigator
- Nicholas T. Domer
- Observations
- 5
- Pages
- 8
- FEI number
- 3007544874
In short: On February 18, 2022, FDA issued a Form 483 with 5 observations to Custom Wire Technologies Inc in Port Washington, Wisconsin (FEI 3007544874) after an inspection that ran Feb 10 – Feb 18, 2022. The investigator was Nicholas T. Domer. Most observations concern production & process controls and cAPA.
At a glance
3 of 5 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for acceptance activities have…
- 02
Procedures have not been adequately established to control product that does not…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
Procedures to control environmental conditions have…
This inspection in context
Nicholas T. Domer
3 documents · 2019–2022
Cites 820.90(a) (nonconforming product) more than any other section. Most of their documents are for sites in Wisconsin.
The firmCustom Wire Technologies Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.80(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom Wire Technologies Inc?
FDA listed 5 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Custom Wire Technologies Inc?
Nicholas T. Domer is named on this Form 483, for the inspection of Feb 10 – Feb 18, 2022. Each investigator has a profile showing what they cite most.
When was Custom Wire Technologies Inc inspected by FDA?
The inspection ran Feb 10 – Feb 18, 2022, and the Form 483 is dated February 18, 2022.
How do I get the full Form 483 for Custom Wire Technologies Inc?
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.