Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-11-16.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Nov 2017 – 16 Nov 2017 | Medical Devices & Rad Health | Clean | |
| 16 Aug 2012 | Not recorded | 483 | View 483 → |
| 8 Oct 2010 | Not recorded | 483 | View 483 → |
| 16 May 2008 | Not recorded | Clean | |
| 12 Feb 2004 | Not recorded | Clean | |
| 18 Aug 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Aug 2012
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Lauren E Skokan
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.180 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind B Braun Medical, Inc.'s 2 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