Baxter Healthcare S.A. /dba Baxter
Form 483 issued February 6, 2015 · Guayama, Puerto Rico
- Inspection
- Jan 21 – Feb 6, 2015
- Investigator
- Libia M. Lugo
- Observations
- 2
- Pages
- 3
- FEI number
- 2650090
In short: On February 6, 2015, FDA issued a Form 483 with 2 observations to Baxter Healthcare S.A. /dba Baxter in Guayama, Puerto Rico (FEI 2650090) after an inspection that ran Jan 21 – Feb 6, 2015. The investigator was Libia M. Lugo. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
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 2 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?
Libia M. Lugo is named on this Form 483, for the inspection of Jan 21 – Feb 6, 2015. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare S.A. /dba Baxter inspected by FDA?
The inspection ran Jan 21 – Feb 6, 2015, and the Form 483 is dated February 6, 2015.
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.