FDA Inspection
Biocare Systems, Inc.Biocare Systems, Inc. – FDA Inspection, Oct 31, 2017
Record Details
This FDA Inspection record concerns Biocare Systems, Inc., with an inspection on October 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d04b6376-d87b-4af8-ab9c-7990384fd3a2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030316
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
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Other FDA inspections of Biocare Systems, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 3, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Biocare Systems, Inc.
- FDA Inspection 853027 - 2013-10-24
- FDA Inspection 701319 - 2010-12-03
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