FDA Inspection
BG Medicine, Inc.BG Medicine, Inc. – FDA Inspection, Sep 20, 2018
Record Details
This FDA Inspection record concerns BG Medicine, Inc., with an inspection on September 20, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7f3896d7-d491-4995-b9d2-6ac4e56a6dd8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066300
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of BG Medicine, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 18, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BG Medicine, Inc.
- FDA Inspection 828717 - 2013-04-18
- FDA Inspection 699354 - 2010-11-18
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