FDA Inspection
Primo Medical Group, IncPrimo Medical Group, Inc – FDA Inspection, Dec 10, 2012
Record Details
This FDA Inspection record concerns Primo Medical Group, Inc, with an inspection on December 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Primo Medical Group, Inc
- Inspection Date
- December 10, 2012
- Product Type
- Devices
View Company Profile
ID · 9e38e375-4030-4782-b6f5-d948e800ae7b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809981
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Primo Medical Group, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2025 | Not classified | New England District Office | |
| September 17, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 24, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Primo Medical Group, Inc
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.