CareFusion 213 LLC
Form 483 issued October 24, 2025 · El Paso, Texas
- Inspection
- Oct 15 – Oct 24, 2025
- Investigators
- Brittny C. Cargo· Inga M. Warr· Michael T. Cyrus
- Observations
- 7
- Pages
- 7
- FEI number
- 3004932373
In short: On October 24, 2025, FDA issued a Form 483 with 7 observations to CareFusion 213 LLC in El Paso, Texas (FEI 3004932373) after an inspection that ran Oct 15 – Oct 24, 2025. The investigators were Brittny C. Cargo, Inga M. Warr, Michael T. Cyrus and Rodney L. Tinzie. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Established test procedures are not documented at…
- 04
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
This inspection in context
Brittny C. Cargo
14 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Louisiana.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CareFusion 213 LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected CareFusion 213 LLC?
Brittny C. Cargo, Inga M. Warr, Michael T. Cyrus and Rodney L. Tinzie are named on this Form 483, for the inspection of Oct 15 – Oct 24, 2025. Each investigator has a profile showing what they cite most.
When was CareFusion 213 LLC inspected by FDA?
The inspection ran Oct 15 – Oct 24, 2025, and the Form 483 is dated October 24, 2025.
How do I get the full Form 483 for CareFusion 213 LLC?
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