Guy & O'Neill Inc
FDA inspection history in Fredonia, Wisconsin, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Fredonia, Wisconsin.
Cited most
Across all Guy & O'Neill observations on file
- 21 CFR 820.30(a)Design controls2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.250(b)Statistical techniques1
- 21 CFR 820.90(a)Nonconforming product1
The complete Guy & O'Neill file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Fredonia, Wisconsin
One Form 483 · 2019 · 6 observations
Latest: Form 483, Aug 22, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-08-22 | 483 Form 483 | Fredonia, Wisconsin | 6 | $99 |
Investigators on these documents
FEI number 3010164716 · most recent document Aug 22, 2019
About Guy & O'Neill Inc
How many FDA Form 483s has Guy & O'Neill Inc received?
FDA Intel has 1 Form 483 on file for Guy & O'Neill Inc; the most recent is dated Aug 22, 2019.
When was Guy & O'Neill Inc last inspected by FDA?
The most recent FDA inspection document on file for Guy & O'Neill Inc is a Form 483 dated Aug 22, 2019, for the site in Fredonia, Wisconsin.
What did FDA cite at Guy & O'Neill Inc?
The regulations cited most in the observations on file for Guy & O'Neill Inc are 21 CFR 820.30(a) (Design controls), 2 times; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.