FDA Inspection
Becton, Dickinson and Company, BD BiosciencesBecton, Dickinson and Company, BD Biosciences – FDA Inspection, Jun 19, 2015
Record Details
This FDA Inspection record concerns Becton, Dickinson and Company, BD Biosciences, with an inspection on June 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 19, 2015
- Product Type
- Devices
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ID · eadc12ba-5079-4d27-a372-99408eb1a17f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 931673
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 1040.10(g)(10)Labels legible, visible, permanent
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Becton, Dickinson and Company, BD Biosciences
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 28, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 12, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 30, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Becton, Dickinson and Company, BD Biosciences
- FDA Inspection 1041888 - 2017-11-28
- FDA Inspection 977012 - 2016-05-12
- FDA Inspection 701077 - 2010-11-30
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