Becton Dickinson Medical Systems
FDA inspection history across 2 sites, 2018 to 2019
- 2
- Close-outs
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2018: one close-out letter and one Form 483; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two close-out letters and one Form 483, at Franklin Lakes, New Jersey and Franklin, Wisconsin.
Cited most
Across all Becton Dickinson Medical Systems observations on file
- 21 CFR 820.70(a)Production and process controls3
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.250(a)Statistical techniques1
- 21 CFR 820.75(a)Process validation1
The complete Becton Dickinson Medical Systems file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Franklin Lakes, New Jersey
Two close-out letters · 2018 to 2019
Latest: Close-out, Feb 11, 2019 →Franklin, Wisconsin
One Form 483 · 2018 · 6 observations
Latest: Form 483, Aug 1, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-02-11 | Close-out Close-out letter | Franklin Lakes, New Jersey | — | $99 |
| 2018-09-14 | Close-out Close-out letter | Franklin Lakes, New Jersey | — | $99 |
| 2018-08-01 | 483 Form 483 | Franklin, Wisconsin | 6 | $99 |
Investigators on these documents
FEI number 1000299851 · most recent document Feb 11, 2019
About Becton Dickinson Medical Systems
How many FDA Form 483s has Becton Dickinson Medical Systems received?
FDA Intel has 1 Form 483 on file for Becton Dickinson Medical Systems; the most recent is dated Aug 1, 2018.
When was Becton Dickinson Medical Systems last inspected by FDA?
The most recent FDA inspection document on file for Becton Dickinson Medical Systems is a Form 483 dated Aug 1, 2018, for the site in Franklin, Wisconsin.
What did FDA cite at Becton Dickinson Medical Systems?
The regulations cited most in the observations on file for Becton Dickinson Medical Systems are 21 CFR 820.70(a) (Production and process controls), 3 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.250(a) (Statistical techniques), 1 time.