FDA Inspection
Mercator Medsystems, Inc.Mercator Medsystems, Inc. – FDA Inspection, Mar 11, 2026
Record Details
This FDA Inspection record concerns Mercator Medsystems, Inc., with an inspection on March 11, 2026, issued by the San Francisco District Office, covering medical devices & rad health.
- Company
- Mercator Medsystems, Inc.
- Inspection Date
- March 11, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · c5c74b66-8473-4e4e-95ca-a79f5cc8128d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1306850
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
1- ISO 13485:2016 Clause 8.2.2Lack of documented justification for not investigating complaint(s)
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mercator Medsystems, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 3, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 12, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 28, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Mercator Medsystems, Inc.
- FDA Inspection 1122346 - 2020-01-27
- FDA Inspection 901345 - 2014-11-03
- FDA Inspection 809228 - 2012-12-12
- FDA Inspection 695968 - 2010-10-28
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.