Becton Dickinson & Company
Form 483 issued July 6, 2017 · Franklin Lakes, New Jersey
- Inspection
- May 15 – Jul 6, 2017
- Investigators
- Dave M. Deroche· Melissa A. Freeman· Yung W. Chan
- Observations
- 7
- Pages
- 10
- FEI number
- 2243072
In short: On July 6, 2017, FDA issued a Form 483 with 7 observations to Becton Dickinson & Company in Franklin Lakes, New Jersey (FEI 2243072) after an inspection that ran May 15 – Jul 6, 2017. The investigators were Dave M. Deroche, Melissa A. Freeman and Yung W. Chan. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 6 of 7 observations.
Most cited: 21 CFR 820.30 (2×) · 820.198 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Design validation did not ensure the device conforms to defined user…
- 02
Design input requirements were…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Dave M. Deroche
2 documents · 2016–2017
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in New Jersey.
The firmBecton Dickinson & Company history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Becton Dickinson & Company?
FDA listed 7 observations on this Form 483, mostly about cAPA, design controls and management controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Becton Dickinson & Company?
Dave M. Deroche, Melissa A. Freeman and Yung W. Chan are named on this Form 483, for the inspection of May 15 – Jul 6, 2017. Each investigator has a profile showing what they cite most.
When was Becton Dickinson & Company inspected by FDA?
The inspection ran May 15 – Jul 6, 2017, and the Form 483 is dated July 6, 2017.
How do I get the full Form 483 for Becton Dickinson & Company?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.