Baxter Healthcare SA / dba Baxter
Form 483 issued November 29, 2023 · Aibonito, Puerto Rico
- Inspection
- Nov 29, 2023
- Investigators
- Ariel Cruz Figueroa· Santos E. Camara
- Observations
- 1
- Pages
- 2
- FEI number
- 2649614
In short: On November 29, 2023, FDA issued a Form 483 with 1 observation to Baxter Healthcare SA / dba Baxter in Aibonito, Puerto Rico (FEI 2649614) after an inspection that ran Nov 29, 2023. The investigators were Ariel Cruz Figueroa and Santos E. Camara. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198(b)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Complaint records are deficient in that they do not include the findings of the…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmBaxter Healthcare SA / dba Baxter history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter Healthcare SA / dba Baxter?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Baxter Healthcare SA / dba Baxter?
Ariel Cruz Figueroa and Santos E. Camara are named on this Form 483, for the inspection of Nov 29, 2023. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare SA / dba Baxter inspected by FDA?
The inspection ran Nov 29, 2023, and the Form 483 is dated November 29, 2023.
How do I get the full Form 483 for Baxter Healthcare SA / 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.