Ohio Medical Corporation
Form 483 issued December 29, 2015 · Gurnee, Illinois
- Inspection
- Mar 16 – Dec 29, 2015
- Investigator
- Gloria C. Abbey Mensah
- Observations
- 11
- Pages
- 12
- FEI number
- 1419185
In short: On December 29, 2015, FDA issued a Form 483 with 11 observations to Ohio Medical Corporation in Gurnee, Illinois (FEI 1419185) after an inspection that ran Mar 16 – Dec 29, 2015. The investigator was Gloria C. Abbey Mensah. 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 7 of 11 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Risk analysis is…
- 03
Procedures for corrective and preventive action have…
- 04
Process validation activities have…
This inspection in context
Gloria C. Abbey Mensah
1 document · 2015
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Illinois.
The firmOhio Medical Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Ohio Medical Corporation?
FDA listed 11 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 Ohio Medical Corporation?
Gloria C. Abbey Mensah is named on this Form 483, for the inspection of Mar 16 – Dec 29, 2015. Each investigator has a profile showing what they cite most.
When was Ohio Medical Corporation inspected by FDA?
The inspection ran Mar 16 – Dec 29, 2015, and the Form 483 is dated December 29, 2015.
How do I get the full Form 483 for Ohio Medical 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.