Baxter Healthcare Corporation
Form 483 issued December 21, 2018 · Jayuya, Puerto Rico
- Inspection
- Dec 3 – Dec 21, 2018
- Investigators
- Jose E. Melendez· Laurimer Kuilan-Torres· Miguel A. Martinez
- Observations
- 12
- Pages
- 28
- FEI number
- 2618677
In short: On December 21, 2018, FDA issued a Form 483 with 12 observations to Baxter Healthcare Corporation in Jayuya, Puerto Rico (FEI 2618677) after an inspection that ran Dec 3 – Dec 21, 2018. The investigators were Jose E. Melendez, Laurimer Kuilan-Torres and Miguel A. Martinez. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and facilities & equipment account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
The written stability program for drug products does not include test intervals based on statistical criteria…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter Healthcare Corporation?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Baxter Healthcare Corporation?
Jose E. Melendez, Laurimer Kuilan-Torres and Miguel A. Martinez are named on this Form 483, for the inspection of Dec 3 – Dec 21, 2018. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare Corporation inspected by FDA?
The inspection ran Dec 3 – Dec 21, 2018, and the Form 483 is dated December 21, 2018.
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.