Overview
- 19 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-16.
At a glance
Inspections
19
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 May 2025 – 16 May 2025 | Human Drugs | 483 | View 483 → |
| 26 Mar 2025 – 9 Apr 2025 | Medical Devices & Rad Health | Clean | |
| 30 Aug 2021 – 1 Sep 2021 | Human Drugs | Clean | |
| 24 May 2018 – 1 Jun 2018 | Medical Devices & Rad Health | Clean | |
| 22 May 2017 – 23 May 2017 | Human Drugs | Clean | |
| 18 Aug 2016 – 26 Aug 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 31 Aug 2015 – 21 Sep 2015 | Human Drugs | 483 | View 483 → |
| 31 Aug 2015 – 2 Sep 2015 | Human Drugs | Clean | |
| 13 Dec 2012 | Not recorded | 483 | View 483 → |
| 8 Aug 2012 | Not recorded | Clean | |
| 1 Sep 2010 | Not recorded | Clean | |
| 24 Sep 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Brian S Keefer5 insp.
Gayle S Lawson2 insp.
James M Mason2 insp.
John M Mastalski2 insp.
Pushpa S Jayasekara1 insp.
Kelly N Kerr1 insp.
Daniel T Lee1 insp.
Thomas E Friel1 insp.
Melissa M Dauksis1 insp.
Jacob M Dyer1 insp.
Margaret E Digennaro1 insp.
Julianne C Mccullough1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind B. Braun Medical, Inc.'s 6 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat