FDA Inspection
Primo Medical GroupPrimo Medical Group – FDA Inspection, Feb 18, 2011
Record Details
This FDA Inspection record concerns Primo Medical Group, with an inspection on February 18, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Primo Medical Group
- Inspection Date
- February 18, 2011
- Product Type
- Devices
View Company Profile
ID · 20aaeb00-0c60-43f0-ae05-973aa2a191e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 711375
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 820.75(b)(2)Documentation of validated process performance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Primo Medical Group
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 3, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 27, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Primo Medical Group
- FDA Inspection 1105935 - 2019-10-03
- FDA Inspection 940287 - 2015-07-27
- FDA Inspection 627537 - 2009-11-06
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