FDA Inspection
BG Medicine, Inc.BG Medicine, Inc. – FDA Inspection, Nov 18, 2010
Record Details
This FDA Inspection record concerns BG Medicine, Inc., with an inspection on November 18, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BG Medicine, Inc.
- Inspection Date
- November 18, 2010
- Product Type
- Devices
View Company Profile
ID · e80fe21a-2eda-43dc-bf3f-cbc61a5a3384
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 699354
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of BG Medicine, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 18, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BG Medicine, Inc.
- FDA Inspection 1066300 - 2018-09-20
- FDA Inspection 828717 - 2013-04-18
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