FDA Inspection 704342 — Insightra Medical Inc
The FDA completed an inspection of Insightra Medical Inc on Dec 15, 2010 in Clarksville, TN. 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
- Dec 15, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Clarksville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3198 | 21 CFR 820.40(b) | Document changes, review and approval, communication |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |