Baxter Healthcare Corporation
FDA inspection history in Jayuya, Puerto Rico, 2015 to 2024
- 4
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2016: one Form 483; 2018: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Three Form 483s, at Jayuya, Puerto Rico.
- 2018The longest 483 on file: 12 observations over 28 pages at Jayuya, Puerto Rico.
- 2024One Form 483, at Jayuya, Puerto Rico.
Cited most
Across all Baxter Healthcare observations on file
- 21 CFR 211.192Production record review5
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.100Written procedures; deviations2
The complete Baxter Healthcare file.
All 4 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
Jayuya, Puerto Rico
Four Form 483s · 2015 to 2024 · 28 observations
Latest: Form 483, Jul 19, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-19 | 483 Form 483 | Jayuya, Puerto Rico | — | $99 |
| 2018-12-21 | 483 Form 483 | Jayuya, Puerto Rico | 12 | $99 |
| 2016-10-03 | 483 Form 483 | Jayuya, Puerto Rico | 10 | $99 |
| 2015-05-01 | 483 Form 483 | Jayuya, Puerto Rico | 6 | $99 |
Investigators on these documents
Jose E. Melendez (2)Erika Englund (1)Jose Velez (1)Laurimer Kuilan-Torres (1)Libia M. Lugo (1)Miguel A. Martinez (1)Santos E. Camara (1)Amir Alavi (1)Yeissa Chabrier-Rosello (1)
FEI number 2618677 · most recent document Jul 19, 2024
About Baxter Healthcare Corporation
How many FDA Form 483s has Baxter Healthcare Corporation received?
FDA Intel has 4 Form 483s on file for Baxter Healthcare Corporation; the most recent is dated Jul 19, 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 Jul 19, 2024, for the site in Jayuya, Puerto Rico.
What did FDA cite at Baxter Healthcare Corporation?
The regulations cited most in the observations on file for Baxter Healthcare Corporation are 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.165 (Testing and release for distribution), 3 times.