FDA Inspection
Invuity, Inc.Invuity, Inc. – FDA Inspection, Aug 15, 2012
Record Details
This FDA Inspection record concerns Invuity, Inc., with an inspection on August 15, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Invuity, Inc.
- Inspection Date
- August 15, 2012
- Product Type
- Devices
View Company Profile
ID · 4b1b89d4-ebe5-4124-9bbd-9be727d54f20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 792464
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Invuity, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 25, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Invuity, Inc.
- FDA Inspection 971657 - 2016-04-14
- FDA Inspection 815734 - 2013-01-25
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.