FDA Inspection
Becton Dickinson & CompanyBecton Dickinson & Company – FDA Inspection, Jul 6, 2017
Record Details
This FDA Inspection record concerns Becton Dickinson & Company, with an inspection on July 6, 2017, issued by the New Jersey District Office, covering medical devices & rad health.
- Company
- Becton Dickinson & Company
- Inspection Date
- July 6, 2017
- Product Type
- Medical Devices & Rad Health
- People
- Dave M. Deroche (Issuing Officer)
- Melissa A. Zuppe
- Yung W. Chan (FDA Associated Person)
View Company Profile
ID · 3959a83a-a2af-4b31-a1e0-163f44cebd34
Inspection Facts
- Inspection number
- 1016971
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Becton Dickinson & Company
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2020 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 18, 2018 | Not classified | New Jersey District Office | |
| November 20, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 3, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Becton Dickinson & Company
- FDA Inspection 1123595 - 2020-03-17
- FDA Inspection 1110691 - 2018-10-18
- FDA Inspection 809888 - 2012-11-20
- FDA Inspection 635424 - 2009-12-03
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.