Baxter Healthcare Corporation
FDA inspection history in Irvine, California, 2013 to 2017
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2013: one warning letter; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One warning letter, at Irvine, California.
- 2017One Form 483, at Irvine, California.
Cited most
Across all Baxter Healthcare observations on file
- 21 CFR 820.100(b)Corrective and preventive action1
- 21 CFR 820.75(a)Process validation1
- 21 CFR 820.90(a)Nonconforming product1
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
Irvine, California
One Form 483 and one warning letter · 2013 to 2017 · 4 observations
Latest: Form 483, Mar 3, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-03-03 | 483 Form 483 | Irvine, California | 4 | $99 |
| 2013-12-19 | Warning letter Warning letter | Irvine, California | — | $99 |
Investigators on these documents
FEI number 2025695 · most recent document Mar 3, 2017
About Baxter Healthcare Corporation
How many FDA Form 483s has Baxter Healthcare Corporation received?
FDA Intel has 1 Form 483 on file for Baxter Healthcare Corporation; the most recent is dated Mar 3, 2017.
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 Mar 3, 2017, for the site in Irvine, California.
What did FDA cite at Baxter Healthcare Corporation?
The regulations cited most in the observations on file for Baxter Healthcare Corporation are 21 CFR 820.100(b) (Corrective and preventive action), 1 time; 21 CFR 820.75(a) (Process validation), 1 time; 21 CFR 820.90(a) (Nonconforming product), 1 time.
Has Baxter Healthcare Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Baxter Healthcare Corporation; the most recent is dated Dec 19, 2013.