C.R. Bard Inc.
Form 483 issued March 2, 2016 · Queensbury, New York
- Inspection
- Feb 10 – Mar 2, 2016
- Investigator
- Scott R. Izyk
- Observations
- 1
- Pages
- 1
- FEI number
- 1313046
In short: On March 2, 2016, FDA issued a Form 483 with 1 observation to C.R. Bard Inc. in Queensbury, New York (FEI 1313046) after an inspection that ran Feb 10 – Mar 2, 2016. The investigator was Scott R. Izyk. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Scott R. Izyk
5 documents · 2015–2016
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmC.R. Bard Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at C.R. Bard Inc.?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected C.R. Bard Inc.?
Scott R. Izyk is named on this Form 483, for the inspection of Feb 10 – Mar 2, 2016. Each investigator has a profile showing what they cite most.
When was C.R. Bard Inc. inspected by FDA?
The inspection ran Feb 10 – Mar 2, 2016, and the Form 483 is dated March 2, 2016.
How do I get the full Form 483 for C.R. Bard Inc.?
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.