Ohio Medical Corporation
FDA inspection history in Gurnee, Illinois, 2009 to 2015
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2009: one warning letter; 2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One warning letter, at Gurnee, Illinois.
- 2015One Form 483, at Gurnee, Illinois.
Cited most
Across all Ohio Medical observations on file
- 21 CFR 820.30(g)Design controls3
- 21 CFR 8201
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.181Device master record1
The complete Ohio Medical file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Gurnee, Illinois
One Form 483 and one warning letter · 2009 to 2015 · 11 observations
Latest: Form 483, Dec 29, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-12-29 | 483 Form 483 | Gurnee, Illinois | 11 | $99 |
| 2009-07-22 | Warning letter Warning letter | Gurnee, Illinois | — | $99 |
Investigators on these documents
FEI number 1419185 · most recent document Dec 29, 2015
About Ohio Medical Corporation
How many FDA Form 483s has Ohio Medical Corporation received?
FDA Intel has 1 Form 483 on file for Ohio Medical Corporation; the most recent is dated Dec 29, 2015.
When was Ohio Medical Corporation last inspected by FDA?
The most recent FDA inspection document on file for Ohio Medical Corporation is a Form 483 dated Dec 29, 2015, for the site in Gurnee, Illinois.
What did FDA cite at Ohio Medical Corporation?
The regulations cited most in the observations on file for Ohio Medical Corporation are 21 CFR 820.30(g) (Design controls), 3 times; 21 CFR 820, 1 time; 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time.
Has Ohio Medical Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Ohio Medical Corporation; the most recent is dated Jul 22, 2009.