FDA Inspection
Bolton Medical Inc.Bolton Medical Inc. – FDA Inspection, Mar 6, 2012
Record Details
This FDA Inspection record concerns Bolton Medical Inc., with an inspection on March 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bolton Medical Inc.
- Inspection Date
- March 6, 2012
- Product Type
- Devices
View Company Profile
ID · af856b92-a01a-4d2b-bb78-93ce1739bff4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 775678
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.46(a)Sponsor securing investigator compliance
- 21 CFR 812.36(e)No IRB approval for treatment use
- 21 CFR 812.40Sponsors" general responsibilities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bolton Medical Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2019 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 16, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 12, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 23, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Bolton Medical Inc.
- FDA Inspection 1111697 - 2019-11-20
- FDA Inspection 1103583 - 2019-09-16
- FDA Inspection 987958 - 2016-09-12
- FDA Inspection 844604 - 2013-08-23
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