FDA Inspection 583433 — Ohio Medical Corporation
The FDA completed an inspection of Ohio Medical Corporation on May 19, 2009 in Gurnee, IL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- May 19, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Gurnee, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3159 | 21 CFR 820.184 | DHR content |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 4189 | 21 CFR 820.198(a) | General |