CareFusion 213 LLC
FDA inspection history across 2 sites, 2015 to 2026
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2015: one Form 483; 2023: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at El Paso, Texas.
- 2023–26Two Form 483s and one warning letter, at El Paso, Texas and Franklin Lakes, New Jersey.
- 2025The longest 483 on file: 7 observations over 7 pages at El Paso, Texas.
Cited most
Across all CareFusion 213 observations on file
- 21 CFR 211.160(a)General requirements3
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.113Control of microbiological contamination1
The complete CareFusion 213 file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
El Paso, Texas
Three Form 483s · 2015 to 2025 · 16 observations
Latest: Form 483, Oct 24, 2025 →Franklin Lakes, New Jersey
One warning letter · 2026
Latest: Warning letter, Apr 30, 2026 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-30 | Warning letter Warning letter | Franklin Lakes, New Jersey | — | $99 |
| 2025-10-24 | 483 Form 483 | El Paso, Texas | 7 | $99 |
| 2023-09-29 | 483 Form 483 | El Paso, Texas | 5 | $99 |
| 2015-06-25 | 483 Form 483 | El Paso, Texas | 4 | $99 |
Investigators on these documents
Rodney L. Tinzie (2)Arie C. Menachem (1)Brittny C. Cargo (1)Francisco J. Mendoza (1)Inga M. Warr (1)Araceli Rey (1)Michael T. Cyrus (1)Oluwasefunm Agbanigo (1)Paul A. Bonneau (1)Margaret M. Annes (1)
FEI number 3004932373 · most recent document Apr 30, 2026
About CareFusion 213 LLC
How many FDA Form 483s has CareFusion 213 LLC received?
FDA Intel has 3 Form 483s on file for CareFusion 213 LLC; the most recent is dated Oct 24, 2025.
When was CareFusion 213 LLC last inspected by FDA?
The most recent FDA inspection document on file for CareFusion 213 LLC is a Form 483 dated Oct 24, 2025, for the site in El Paso, Texas.
What did FDA cite at CareFusion 213 LLC?
The regulations cited most in the observations on file for CareFusion 213 LLC are 21 CFR 211.160(a) (General requirements), 3 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 3 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 2 times.
Has CareFusion 213 LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for CareFusion 213 LLC; the most recent is dated Apr 30, 2026.