FDA Inspection
Biosphere Medical IncBiosphere Medical Inc – FDA Inspection, Nov 17, 2014
Record Details
This FDA Inspection record concerns Biosphere Medical Inc, with an inspection on November 17, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biosphere Medical Inc
- Inspection Date
- November 17, 2014
- Product Type
- Devices
View Company Profile
ID · 62382e27-9c1a-43b7-ba47-05b15b0f957e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 904983
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.150(b)(8)Sponsor report of use without informed consent
- 21 CFR 812.25(e)Sponsor"s lack of written monitoring procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biosphere Medical Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biosphere Medical Inc
- FDA Inspection 729149 - 2011-06-06
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