FDA Inspection
Insightra Medical IncInsightra Medical Inc – FDA Inspection, Dec 15, 2010
Record Details
This FDA Inspection record concerns Insightra Medical Inc, with an inspection on December 15, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Insightra Medical Inc
- Inspection Date
- December 15, 2010
- Product Type
- Devices
View Company Profile
ID · e220abee-e642-49e4-93c9-a11240987853
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 704342
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(b)Document changes, review and approval, communication
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Insightra Medical Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2026 | Not classified | New Orleans District Office | |
| January 27, 2025 | OAI | New Orleans District Office | Compliance: Medical Devices |
| June 19, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 24, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Insightra Medical Inc
- FDA Inspection 1298946 - 2026-01-08
- FDA Inspection 1259305 - 2025-01-27
- FDA Inspection 1056174 - 2018-06-19
- FDA Inspection 915280 - 2015-02-24
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