Baxter Healthcare Corporation
Form 483 issued May 1, 2015 · Jayuya, Puerto Rico
- Inspection
- Apr 6 – May 1, 2015
- Investigator
- Jose E. Melendez
- Observations
- 6
- Pages
- 7
- FEI number
- 2618677
In short: On May 1, 2015, FDA issued a Form 483 with 6 observations to Baxter Healthcare Corporation in Jayuya, Puerto Rico (FEI 2618677) after an inspection that ran Apr 6 – May 1, 2015. The investigator was Jose E. Melendez. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not fully followed. There are…
- 02
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use…
- 03
Each lot of components and closures is not withheld from use until the lot has been…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
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 6 observations on this Form 483, mostly about quality system, materials and production. The opening words of each observation are shown on this page.
Who inspected Baxter Healthcare Corporation?
Jose E. Melendez is named on this Form 483, for the inspection of Apr 6 – May 1, 2015. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare Corporation inspected by FDA?
The inspection ran Apr 6 – May 1, 2015, and the Form 483 is dated May 1, 2015.
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.