Baxter Healthcare SA / dba Baxter
Form 483 issued June 8, 2015 · Aibonito, Puerto Rico
- Inspection
- May 6 – Jun 8, 2015
- Investigators
- Laiza V. Garcia· Miguel A. Martinez
- Observations
- 1
- Pages
- 3
- FEI number
- 2649614
In short: On June 8, 2015, 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 May 6 – Jun 8, 2015. The investigators were Laiza V. Garcia and Miguel A. Martinez. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.250 (statistical techniques).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.250(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Sampling plans are not based on valid statistical rationale. The sample size established as a monitoring…
This inspection in context
Laiza V. Garcia
5 documents · 2015–2019
Cites 820.100 (corrective and preventive action) 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 820.250(b)
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 production & process controls. The most-cited regulation is 21 CFR 820.250 (statistical techniques). The opening words of each observation are shown on this page.
Who inspected Baxter Healthcare SA / dba Baxter?
Laiza V. Garcia and Miguel A. Martinez are named on this Form 483, for the inspection of May 6 – Jun 8, 2015. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare SA / dba Baxter inspected by FDA?
The inspection ran May 6 – Jun 8, 2015, and the Form 483 is dated June 8, 2015.
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.