Baxter Healthcare Corporation
Form 483 issued October 3, 2016 · Jayuya, Puerto Rico
- Inspection
- Aug 22 – Oct 3, 2016
- Investigators
- Erika Englund· Jose Velez· Libia M. Lugo
- Observations
- 10
- Pages
- 21
- FEI number
- 2618677
In short: On October 3, 2016, FDA issued a Form 483 with 10 observations to Baxter Healthcare Corporation in Jayuya, Puerto Rico (FEI 2618677) after an inspection that ran Aug 22 – Oct 3, 2016. The investigators were Erika Englund, Jose Velez, Libia M. Lugo and Yeissa Chabrier-Rosello. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
The responsibilities and procedures applicable to the quality control unit are not fully followed. There are…
This inspection in context
Erika Englund
1 document · 2016
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmBaxter Healthcare Corporation history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter Healthcare Corporation?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Baxter Healthcare Corporation?
Erika Englund, Jose Velez, Libia M. Lugo and Yeissa Chabrier-Rosello are named on this Form 483, for the inspection of Aug 22 – Oct 3, 2016. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare Corporation inspected by FDA?
The inspection ran Aug 22 – Oct 3, 2016, and the Form 483 is dated October 3, 2016.
How do I get the full Form 483 for Baxter Healthcare Corporation?
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.