Baxter Healthcare SA / dba Baxter
FDA inspection history across 2 sites, 2014 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one warning letter; 2015: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–15One warning letter and one Form 483, at Deerfield, Illinois and Aibonito, Puerto Rico.
- 2015The longest 483 on file: 1 observation over 3 pages at Aibonito, Puerto Rico.
- 2023One Form 483, at Aibonito, Puerto Rico.
Cited most
Across all Baxter Healthcare SA / dba Baxter observations on file
- 21 CFR 211.198(b)(2)Complaint files1
- 21 CFR 820.250(b)Statistical techniques1
The complete Baxter Healthcare SA / dba Baxter file.
All 3 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
Aibonito, Puerto Rico
Two Form 483s · 2015 to 2023 · 2 observations
Latest: Form 483, Nov 29, 2023 →Deerfield, Illinois
One warning letter · 2014
Latest: Warning letter, Jul 17, 2014 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-11-29 | 483 Form 483 | Aibonito, Puerto Rico | 1 | $99 |
| 2015-06-08 | 483 Form 483 | Aibonito, Puerto Rico | 1 | $99 |
| 2014-07-17 | Warning letter Warning letter | Deerfield, Illinois | — | $99 |
Investigators on these documents
Ariel Cruz Figueroa (1)Laiza V. Garcia (1)Miguel A. Martinez (1)Santos E. Camara (1)
FEI number 2649614 · most recent document Nov 29, 2023
About Baxter Healthcare SA / dba Baxter
How many FDA Form 483s has Baxter Healthcare SA / dba Baxter received?
FDA Intel has 2 Form 483s on file for Baxter Healthcare SA / dba Baxter; the most recent is dated Nov 29, 2023.
When was Baxter Healthcare SA / dba Baxter last inspected by FDA?
The most recent FDA inspection document on file for Baxter Healthcare SA / dba Baxter is a Form 483 dated Nov 29, 2023, for the site in Aibonito, Puerto Rico.
What did FDA cite at Baxter Healthcare SA / dba Baxter?
The regulations cited most in the observations on file for Baxter Healthcare SA / dba Baxter are 21 CFR 211.198(b)(2) (Complaint files), 1 time; 21 CFR 820.250(b) (Statistical techniques), 1 time.
Has Baxter Healthcare SA / dba Baxter received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Baxter Healthcare SA / dba Baxter; the most recent is dated Jul 17, 2014.