FDA Inspection
Becton Dickinson and CompanyBecton Dickinson and Company – FDA Inspection, Jan 10, 2017
Record Details
This FDA Inspection record concerns Becton Dickinson and Company, with an inspection on January 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · df75192a-1979-4c19-a4c5-a1567341348c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 999001
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
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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 | |
| March 9, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 29, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 917418 - 2015-03-09
- FDA Inspection 899388 - 2014-08-29
- FDA Inspection 710684 - 2011-02-17
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