CareFusion 213 LLC
Form 483 issued September 29, 2023 · El Paso, Texas
- Inspection
- Sep 18 – Sep 29, 2023
- Investigators
- Margaret M. Annes· Oluwasefunm Agbanigo· Rodney L. Tinzie
- Observations
- 5
- Pages
- 6
- FEI number
- 3004932373
In short: On September 29, 2023, FDA issued a Form 483 with 5 observations to CareFusion 213 LLC in El Paso, Texas (FEI 3004932373) after an inspection that ran Sep 18 – Sep 29, 2023. The investigators were Margaret M. Annes, Oluwasefunm Agbanigo and Rodney L. Tinzie. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and quality system account for 3 of 5 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
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 03
Representative samples are not taken of each shipment of each lot of components…
- 04
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CareFusion 213 LLC?
FDA listed 5 observations on this Form 483, mostly about materials, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected CareFusion 213 LLC?
Margaret M. Annes, Oluwasefunm Agbanigo and Rodney L. Tinzie are named on this Form 483, for the inspection of Sep 18 – Sep 29, 2023. Each investigator has a profile showing what they cite most.
When was CareFusion 213 LLC inspected by FDA?
The inspection ran Sep 18 – Sep 29, 2023, and the Form 483 is dated September 29, 2023.
How do I get the full Form 483 for CareFusion 213 LLC?
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