Baxter Healthcare Corporation
Form 483 issued March 3, 2017 · Irvine, California
- Inspection
- Feb 21 – Mar 3, 2017
- Investigators
- Charles L. Larson· Sean T. Creighton
- Observations
- 4
- Pages
- 4
- FEI number
- 2025695
In short: On March 3, 2017, FDA issued a Form 483 with 4 observations to Baxter Healthcare Corporation in Irvine, California (FEI 2025695) after an inspection that ran Feb 21 – Mar 3, 2017. The investigators were Charles L. Larson and Sean T. Creighton. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Process validation activities have…
- 02
Corrective and preventive action activities and/or results have…
- 03
Procedures have not been adequately established to control product that does not conform…
- 04
: Not…
This inspection in context
Charles L. Larson
2 documents · 2017–2022
Cites 820.100(b) (corrective and preventive action) more than any other section. Most of their documents are for sites in Arizona.
The firmBaxter Healthcare Corporation history
All 2 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 Baxter Healthcare Corporation?
FDA listed 4 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Baxter Healthcare Corporation?
Charles L. Larson and Sean T. Creighton are named on this Form 483, for the inspection of Feb 21 – Mar 3, 2017. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare Corporation inspected by FDA?
The inspection ran Feb 21 – Mar 3, 2017, and the Form 483 is dated March 3, 2017.
How do I get the full Form 483 for Baxter Healthcare Corporation?
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.