557428
Sendx Medical Inc — FEI 2027541
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 20, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 540 | 21 CFR 820.70(b) | Production and process changes - failure to follow procedure |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |