FDA Inspection 557428 — Sendx Medical Inc
The FDA completed an inspection of Sendx Medical Inc on Jan 20, 2009 in Carlsbad, CA. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 20, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |