Company
United StatesBiosphere Medical Inc, Rockland, MA – FDA Inspections
Inspection records and compliance data for Biosphere Medical Inc in Rockland, Massachusetts. 2 FDA inspections on record, last inspected November 17, 2014.
Company Profile
This profile covers Biosphere Medical Inc based in Rockland, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 6, 2011. Last inspected November 17, 2014.
Most cited issue areas
- Sponsor report of use without informed consent1 inspection
- Sponsor"s lack of written monitoring procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 17, 2014 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 904983 |
| June 6, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 729149 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biosphere Medical Inc
FEI Number
3002975604
Address
1050 Hingham St, Rockland, Massachusetts 02370, United States
Country
United States
ID: 6bca7b67-de3e-45eb-a0a2-34f15864f161