740437
Owen Mumford USA, Inc. — FEI 1000219614
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 10, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4437 | 21 CFR 803.40(b) | Report of malfunction likely to cause death or injury |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |