CareFusion 303, Inc.
FDA inspection history across 2 sites, 2020 to 2024
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2020: two Form 483s; 2024: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2020Two Form 483s, at San Diego, California.
- 2020The longest 483 on file: 8 observations over 13 pages.
- 2024One warning letter, at Franklin Lakes, New Jersey.
Cited most
Across all CareFusion 303 observations on file
- 21 CFR 820.198Complaint files4
- 21 CFR 820.30Design controls4
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2
- 21 CFR 806.10Reports of corrections and removals2
- 21 CFR 820.100Corrective and preventive action2
The complete CareFusion 303 file.
All 3 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
Franklin Lakes, New Jersey
One warning letter · 2024
Latest: Warning letter, Nov 22, 2024 →San Diego, California
One Form 483 · 2020 · 8 observations
Latest: Form 483, Mar 2, 2020 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-22 | Warning letter Warning letter | Franklin Lakes, New Jersey | — | $99 |
| 2020-04-06 | 483 Form 483 | — | 8 | $99 |
| 2020-03-02 | 483 Form 483 | San Diego, California | 8 | $99 |
Investigators on these documents
FEI number 2016493 · most recent document Nov 22, 2024
About CareFusion 303, Inc.
How many FDA Form 483s has CareFusion 303, Inc. received?
FDA Intel has 2 Form 483s on file for CareFusion 303, Inc.; the most recent is dated Apr 6, 2020.
When was CareFusion 303, Inc. last inspected by FDA?
The most recent FDA inspection document on file for CareFusion 303, Inc. is a Form 483 dated Apr 6, 2020.
What did FDA cite at CareFusion 303, Inc.?
The regulations cited most in the observations on file for CareFusion 303, Inc. are 21 CFR 820.198 (Complaint files), 4 times; 21 CFR 820.30 (Design controls), 4 times; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 2 times.
Has CareFusion 303, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for CareFusion 303, Inc.; the most recent is dated Nov 22, 2024.