Baxter Healthcare Corporation
Amended 483 issued February 9, 2024 · Marion, North Carolina
- Inspection
- Jan 29 – Feb 9, 2024
- Investigators
- Demario L. Walls· Libia M. Lugo· Susan T. Hadman
- Observations
- 7
- Pages
- 11
- FEI number
- 1025114
In short: On February 9, 2024, FDA issued a Amended 483 with 7 observations to Baxter Healthcare Corporation in Marion, North Carolina (FEI 1025114) after an inspection that ran Jan 29 – Feb 9, 2024. The investigators were Demario L. Walls, Libia M. Lugo, Susan T. Hadman and Veronica Fuentes. Most observations concern quality system and production.
At a glance
Quality system and production account for 5 of 7 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
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 03
Control procedures fail to include adequacy of mixing to…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
3 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Demario L. Walls
18 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmBaxter Healthcare Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Baxter Healthcare Corporation?
FDA listed 7 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Baxter Healthcare Corporation?
Demario L. Walls, Libia M. Lugo, Susan T. Hadman and Veronica Fuentes are named on this Amended 483, for the inspection of Jan 29 – Feb 9, 2024. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare Corporation inspected by FDA?
The inspection ran Jan 29 – Feb 9, 2024, and the Amended 483 is dated February 9, 2024.
How do I get the full Amended 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.