809816
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 18, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Solon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |