CareFusion 213 LLC
Form 483 issued June 25, 2015 · El Paso, Texas
- Inspection
- Jun 17 – Jun 25, 2015
- Investigators
- Araceli Rey· Arie C. Menachem· Francisco J. Mendoza
- Observations
- 4
- Pages
- 3
- FEI number
- 3004932373
In short: On June 25, 2015, FDA issued a Form 483 with 4 observations to CareFusion 213 LLC in El Paso, Texas (FEI 3004932373) after an inspection that ran Jun 17 – Jun 25, 2015. The investigators were Araceli Rey, Arie C. Menachem, Francisco J. Mendoza and Paul A. Bonneau. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 02
Equipment for adequate control over air pressure, micro-organisms, and dust is not provided when appropriate for…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
The identity of each component of a drug product is not verified by conducting at least…
This inspection in context
Araceli Rey
1 document · 2015
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmCareFusion 213 LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CareFusion 213 LLC?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected CareFusion 213 LLC?
Araceli Rey, Arie C. Menachem, Francisco J. Mendoza and Paul A. Bonneau are named on this Form 483, for the inspection of Jun 17 – Jun 25, 2015. Each investigator has a profile showing what they cite most.
When was CareFusion 213 LLC inspected by FDA?
The inspection ran Jun 17 – Jun 25, 2015, and the Form 483 is dated June 25, 2015.
How do I get the full Form 483 for CareFusion 213 LLC?
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.