Baxter SA
FDA inspection history in Lessines, Belgium, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Lessines, Belgium.
Cited most
Across all Baxter observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
The complete Baxter file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Lessines, Belgium
One Form 483 · 2019 · 9 observations
Latest: Form 483, Sep 27, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-09-27 | 483 Form 483 | Lessines, Belgium | 9 | $99 |
Investigators on these documents
Julianne C. McCullough (1)Ofthis Pla Julianne McCullough (1)
FEI number 3005468265 · most recent document Sep 27, 2019
About Baxter SA
How many FDA Form 483s has Baxter SA received?
FDA Intel has 1 Form 483 on file for Baxter SA; the most recent is dated Sep 27, 2019.
When was Baxter SA last inspected by FDA?
The most recent FDA inspection document on file for Baxter SA is a Form 483 dated Sep 27, 2019, for the site in Lessines, Belgium.
What did FDA cite at Baxter SA?
The regulations cited most in the observations on file for Baxter SA are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.