FDA Inspection 920811 — Ohio Medical Corporation
The FDA completed an inspection of Ohio Medical Corporation on Dec 29, 2015 in Gurnee, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 29, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gurnee, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |