Baxter Healthcare S.A. /dba Baxter
Form 483 issued March 26, 2025 · Guayama, Puerto Rico
- Inspection
- Mar 24 – Mar 26, 2025
- Investigators
- Christian F. Gomez Lugo· Jose Velez· Yoriann M. Cabrera Bartolomei
- Observations
- 4
- Pages
- 7
- FEI number
- 2650090
In short: On March 26, 2025, FDA issued a Form 483 with 4 observations to Baxter Healthcare S.A. /dba Baxter in Guayama, Puerto Rico (FEI 2650090) after an inspection that ran Mar 24 – Mar 26, 2025. The investigators were Christian F. Gomez Lugo, Jose Velez and Yoriann M. Cabrera Bartolomei. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Christian F. Gomez Lugo
6 documents · 2024–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in North Carolina.
The firmBaxter Healthcare S.A. /dba Baxter history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter Healthcare S.A. /dba Baxter?
FDA listed 4 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Baxter Healthcare S.A. /dba Baxter?
Christian F. Gomez Lugo, Jose Velez and Yoriann M. Cabrera Bartolomei are named on this Form 483, for the inspection of Mar 24 – Mar 26, 2025. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare S.A. /dba Baxter inspected by FDA?
The inspection ran Mar 24 – Mar 26, 2025, and the Form 483 is dated March 26, 2025.
How do I get the full Form 483 for Baxter Healthcare S.A. /dba Baxter?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.