Guy & O'Neill Inc
Form 483 issued August 22, 2019 · Fredonia, Wisconsin
- Inspection
- Aug 5 – Aug 22, 2019
- Investigator
- Michelle J. Glembin
- Observations
- 6
- Pages
- 7
- FEI number
- 3010164716
In short: On August 22, 2019, FDA issued a Form 483 with 6 observations to Guy & O'Neill Inc in Fredonia, Wisconsin (FEI 3010164716) after an inspection that ran Aug 5 – Aug 22, 2019. The investigator was Michelle J. Glembin. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The results of design validation, including method(s), were not adequately documented in…
- 02
Sampling plans are not based…
- 03
Procedures for design control…
- 04
Procedures have not been adequately established to control product that does not…
This inspection in context
Michelle J. Glembin
5 documents · 2015–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Wisconsin.
The firmGuy & O'Neill Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Guy & O'Neill Inc?
FDA listed 6 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Guy & O'Neill Inc?
Michelle J. Glembin is named on this Form 483, for the inspection of Aug 5 – Aug 22, 2019. Each investigator has a profile showing what they cite most.
When was Guy & O'Neill Inc inspected by FDA?
The inspection ran Aug 5 – Aug 22, 2019, and the Form 483 is dated August 22, 2019.
How do I get the full Form 483 for Guy & O'Neill 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.