Baxter Healthcare Corporation
FDA inspection history in Marion, North Carolina, 2023 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2024: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24One Form 483 and one amended 483, at Marion, North Carolina.
- 2024The longest 483 on file: 7 observations over 11 pages at Marion, North Carolina.
Cited most
Across all Baxter Healthcare observations on file
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products2
- 21 CFR 211.160(a)General requirements2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.192Production record review1
The complete Baxter Healthcare file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Marion, North Carolina
One amended 483 and one Form 483 · 2023 to 2024 · 12 observations
Latest: Form 483, Feb 9, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-09 | Amended 483 Amended 483 | Marion, North Carolina | 7 | $99 |
| 2023-10-31 | 483 Form 483 | Marion, North Carolina | 5 | $99 |
Investigators on these documents
Christopher J. Adams (1)Demario L. Walls (1)Libia M. Lugo (1)Scott Ballard (1)Susan T. Hadman (1)Veronica Fuentes (1)
FEI number 1025114 · most recent document Feb 9, 2024
About Baxter Healthcare Corporation
How many FDA Form 483s has Baxter Healthcare Corporation received?
FDA Intel has 2 Form 483s on file for Baxter Healthcare Corporation; the most recent is dated Feb 9, 2024.
When was Baxter Healthcare Corporation last inspected by FDA?
The most recent FDA inspection document on file for Baxter Healthcare Corporation is a Form 483 dated Feb 9, 2024, for the site in Marion, North Carolina.
What did FDA cite at Baxter Healthcare Corporation?
The regulations cited most in the observations on file for Baxter Healthcare Corporation are 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.160(a) (General requirements), 2 times.