Baxter Healthcare Corporation
FDA inspection history across 4 sites, 2001 to 2017
- 5
- Warning letters
- 3
- Close-outs
- 2
- Form 483s
Every document, by year
- Close-out
- Form 483
- Warning letter
2001: two warning letters; 2003: one warning letter; 2004: two warning letters; 2010: one Form 483; 2014: one Form 483; 2015: one close-out letter; 2017: two close-out letters.
The story so far
Built from the dates and citations on the documents themselves.
- 2001–04Five warning letters, at Deerfield, Illinois and Westlake Village, California.
- 2010One Form 483, at Cleveland, Mississippi.
- 2014–17Three close-out letters and one Form 483, at Cleveland, Mississippi; Deerfield, Illinois and Irvine, California.
- 2014The longest 483 on file: 5 observations over 2 pages at Cleveland, Mississippi.
Cited most
Across all Baxter Healthcare observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment1
The complete Baxter Healthcare file.
All 10 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Deerfield, Illinois
Two close-out letters and two warning letters · 2001 to 2017
Latest: Close-out, Feb 8, 2017 →Cleveland, Mississippi
Two Form 483s · 2010 to 2014 · 9 observations
Latest: Form 483, Jan 23, 2014 →Westlake Village, California
Two warning letters · 2004
Latest: Warning letter, May 25, 2004 →Irvine, California
One close-out letter · 2017
Latest: Close-out, May 12, 2017 →
Also: one document not tied to a site.
Documents
10 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-05-12 | Close-out Close-out letter | Irvine, California | — | $99 |
| 2017-02-08 | Close-out Close-out letter | Deerfield, Illinois | — | $99 |
| 2015-10-02 | Close-out Close-out letter | Deerfield, Illinois | — | $99 |
| 2014-01-23 | 483 Form 483 | Cleveland, Mississippi | 5 | $99 |
| 2010-02-05 | 483 Form 483 | Cleveland, Mississippi | 4 | $99 |
| 2004-05-25 | Warning letter Warning letter | Westlake Village, California | — | $99 |
| 2004-05-11 | Warning letter Warning letter | Westlake Village, California | — | $99 |
| 2003-04-02 | Warning letter Warning letter | — | — | $99 |
| 2001-11-02 | Warning letter Warning letter | Deerfield, Illinois | — | $99 |
| 2001-08-22 | Warning letter Warning letter | Deerfield, Illinois | — | $99 |
Investigators on these documents
FEI number 1019003 · most recent document May 12, 2017
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 Jan 23, 2014.
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 Jan 23, 2014, for the site in Cleveland, Mississippi.
What did FDA cite at Baxter Healthcare Corporation?
The regulations cited most in the observations on file for Baxter Healthcare Corporation are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times; 21 CFR 211.165 (Testing and release for distribution), 1 time.
Has Baxter Healthcare Corporation received an FDA warning letter?
Yes. FDA Intel has 5 FDA warning letters on file for Baxter Healthcare Corporation; the most recent is dated May 25, 2004.