Baxter Healthcare S.A. /dba Baxter
FDA inspection history in Guayama, Puerto Rico, 2015 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Guayama, Puerto Rico.
- 2025One Form 483, at Guayama, Puerto Rico.
- 2025The longest 483 on file: 4 observations over 7 pages at Guayama, Puerto Rico.
Cited most
Across all Baxter Healthcare S.A. /dba Baxter observations on file
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.192Production record review1
The complete Baxter Healthcare S.A. /dba Baxter 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
Guayama, Puerto Rico
Two Form 483s · 2015 to 2025 · 6 observations
Latest: Form 483, Mar 26, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-26 | 483 Form 483 | Guayama, Puerto Rico | 4 | $99 |
| 2015-02-06 | 483 Form 483 | Guayama, Puerto Rico | 2 | $99 |
Investigators on these documents
Christian F. Gomez Lugo (1)Jose Velez (1)Libia M. Lugo (1)Yoriann M. Cabrera Bartolomei (1)
FEI number 2650090 · most recent document Mar 26, 2025
About Baxter Healthcare S.A. /dba Baxter
How many FDA Form 483s has Baxter Healthcare S.A. /dba Baxter received?
FDA Intel has 2 Form 483s on file for Baxter Healthcare S.A. /dba Baxter; the most recent is dated Mar 26, 2025.
When was Baxter Healthcare S.A. /dba Baxter last inspected by FDA?
The most recent FDA inspection document on file for Baxter Healthcare S.A. /dba Baxter is a Form 483 dated Mar 26, 2025, for the site in Guayama, Puerto Rico.
What did FDA cite at Baxter Healthcare S.A. /dba Baxter?
The regulations cited most in the observations on file for Baxter Healthcare S.A. /dba Baxter are 21 CFR 211.22(d) (Responsibilities of quality control unit), 2 times; 21 CFR 211.192 (Production record review), 1 time.