Becton Dickinson Medical Systems
Form 483 issued August 1, 2018 · Franklin, Wisconsin
- Inspection
- May 16 – Aug 1, 2018
- Investigator
- Nicholas Z. Lu
- Observations
- 6
- Pages
- 8
- FEI number
- 1000299851
In short: On August 1, 2018, FDA issued a Form 483 with 6 observations to Becton Dickinson Medical Systems in Franklin, Wisconsin (FEI 1000299851) after an inspection that ran May 16 – Aug 1, 2018. The investigator was Nicholas Z. Lu. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
5 of 6 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to control environmental conditions…
- 02
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect…
- 03
Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process…
- 04
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Nicholas Z. Lu
10 documents · 2018–2024
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Illinois.
The firmBecton Dickinson Medical Systems history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Becton Dickinson Medical Systems?
FDA listed 6 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Becton Dickinson Medical Systems?
Nicholas Z. Lu is named on this Form 483, for the inspection of May 16 – Aug 1, 2018. Each investigator has a profile showing what they cite most.
When was Becton Dickinson Medical Systems inspected by FDA?
The inspection ran May 16 – Aug 1, 2018, and the Form 483 is dated August 1, 2018.
How do I get the full Form 483 for Becton Dickinson Medical Systems?
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.