FDA Inspection
Becton Dickinson and CompanyBecton Dickinson and Company – FDA Inspection, Aug 29, 2014
Record Details
This FDA Inspection record concerns Becton Dickinson and Company, with an inspection on August 29, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Becton Dickinson and Company
- Inspection Date
- August 29, 2014
- Product Type
- Devices
View Company Profile
ID · a9c09024-052a-41ec-8873-8234fca31316
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 899388
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of Becton Dickinson and Company
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 9, 2018 | Not classified | Atlanta District Office | |
| January 10, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 9, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 17, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Becton Dickinson and Company
- FDA Inspection 1219487 - 2023-09-15
- FDA Inspection 1055853 - 2018-05-09
- FDA Inspection 999001 - 2017-01-10
- FDA Inspection 917418 - 2015-03-09
- FDA Inspection 710684 - 2011-02-17
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