B. Braun Medical Inc
FDA inspection history across 2 sites, 2001 to 2023
- 4
- Form 483s
- 3
- Warning letters
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
- Warning letter
2001: one warning letter; 2002: one warning letter; 2017: one warning letter; 2018: one Form 483; 2020: two Form 483s and one close-out letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2001–02Two warning letters, at Allentown, Pennsylvania.
- 2017–20Three Form 483s, one warning letter and one close-out letter, at Irvine, California.
- 2018The longest 483 on file: 8 observations over 10 pages at Irvine, California.
- 2023One Form 483, at Irvine, California.
Cited most
Across all B. Braun Medical observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.165(c)Testing and release for distribution2
- 21 CFR 211.194(a)(1)Laboratory records2
- 21 CFR 211.65Equipment construction2
The complete B. Braun Medical file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Irvine, California
Four Form 483s, one close-out letter and one warning letter · 2017 to 2023 · 17 observations
Latest: Form 483, Dec 15, 2023 →Allentown, Pennsylvania
One warning letter · 2001
Latest: Warning letter, Sep 17, 2001 →
Also: one document not tied to a site.
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-15 | 483 Form 483 | Irvine, California | 3 | $99 |
| 2020-10-22 | Close-out Close-out letter | Irvine, California | — | $99 |
| 2020-07-23 | 483 Form 483 | Irvine, California | 3 | $99 |
| 2020-07-23 | 483 Form 483 | Irvine, California | 3 | $99 |
| 2018-06-29 | 483 Form 483 | Irvine, California | 8 | $99 |
| 2017-05-12 | Warning letter Warning letter | Irvine, California | — | $99 |
| 2002-11-07 | Warning letter Warning letter | — | — | $99 |
| 2001-09-17 | Warning letter Warning letter | Allentown, Pennsylvania | — | $99 |
Investigators on these documents
Walden H. Lee (3)Uttaniti Limchumroon (2)Amanda L. Fyles (1)Carrie A. Hughes (1)Evelyn Wong (1)
FEI number 2021236 · most recent document Dec 15, 2023
About B. Braun Medical Inc
How many FDA Form 483s has B. Braun Medical Inc received?
FDA Intel has 4 Form 483s on file for B. Braun Medical Inc; the most recent is dated Dec 15, 2023.
When was B. Braun Medical Inc last inspected by FDA?
The most recent FDA inspection document on file for B. Braun Medical Inc is a Form 483 dated Dec 15, 2023, for the site in Irvine, California.
What did FDA cite at B. Braun Medical Inc?
The regulations cited most in the observations on file for B. Braun Medical Inc are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times; 21 CFR 211.165(c) (Testing and release for distribution), 2 times.
Has B. Braun Medical Inc received an FDA warning letter?
Yes. FDA Intel has 3 FDA warning letters on file for B. Braun Medical Inc; the most recent is dated May 12, 2017.