Baxter Healthcare Corporation
Form 483 issued October 31, 2023 · Marion, North Carolina
- Inspection
- Oct 23 – Oct 31, 2023
- Investigators
- Christopher J. Adams· Scott Ballard
- Observations
- 5
- Pages
- 5
- FEI number
- 1025114
In short: On October 31, 2023, FDA issued a Form 483 with 5 observations to Baxter Healthcare Corporation in Marion, North Carolina (FEI 1025114) after an inspection that ran Oct 23 – Oct 31, 2023. The investigators were Christopher J. Adams and Scott Ballard. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Your examination and testing of samples did not assure that the drug product and in-process…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Christopher J. Adams
3 documents · 2023–2025
Cites 1271.190 (facilities) more than any other section. Most of their documents are for sites in North Carolina.
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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter Healthcare Corporation?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Baxter Healthcare Corporation?
Christopher J. Adams and Scott Ballard are named on this Form 483, for the inspection of Oct 23 – Oct 31, 2023. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare Corporation inspected by FDA?
The inspection ran Oct 23 – Oct 31, 2023, and the Form 483 is dated October 31, 2023.
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.