FDA Inspection
MedAire, Inc.MedAire, Inc. – FDA Inspection, Feb 11, 2010
Record Details
This FDA Inspection record concerns MedAire, Inc., with an inspection on February 11, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MedAire, Inc.
- Inspection Date
- February 11, 2010
- Product Type
- Devices
View Company Profile
ID · 9ed7a556-477b-4368-9d4f-0a27d4fe178a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 645068
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MedAire, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 12, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 7, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MedAire, Inc.
- FDA Inspection 1187470 - 2022-10-13
- FDA Inspection 1026160 - 2017-05-12
- FDA Inspection 878246 - 2014-05-07
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.