CareFusion 303, Inc.
Form 483 issued April 6, 2020
- Inspection
- Mar 2 – Apr 6, 2020
- Investigator
- Janet Pulver
- Observations
- 8
- Pages
- 13
- FEI number
- 2016493
In short: On April 6, 2020, FDA issued a Form 483 with 8 observations to CareFusion 303, Inc. (FEI 2016493) after an inspection that ran Mar 2 – Apr 6, 2020. The investigator was Janet Pulver. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
5 of 8 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 04
A violation of the FD&C Act involving a device which might present a risk to health…
This inspection in context
Janet Pulver
10 documents · 2014–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmCareFusion 303, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CareFusion 303, Inc.?
FDA listed 8 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected CareFusion 303, Inc.?
Janet Pulver is named on this Form 483, for the inspection of Mar 2 – Apr 6, 2020. Each investigator has a profile showing what they cite most.
When was CareFusion 303, Inc. inspected by FDA?
The inspection ran Mar 2 – Apr 6, 2020, and the Form 483 is dated April 6, 2020.
How do I get the full Form 483 for CareFusion 303, 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.