Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-02-22.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Feb 2017 – 22 Feb 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Oct 2013 – 7 Oct 2013 | Medical Devices & Rad Health | Clean | |
| 4 Dec 2009 | Not recorded | 483 | View 483 → |
| 5 Aug 2004 | Not recorded | Clean | |
| 5 Apr 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Dec 2009
21 CFR 820.70(g)(2)
Periodic equipment inspection lack of or inadequate procedu
Cited by Bonnie E Pierson, Rodney D Combs, Aisha N Rashad
Investigators
FDA investigators tied to this site in the record.
Eric C Fox1 insp.
Matthew J Morrison1 insp.
Nicole J Conklin1 insp.
Bonnie E Pierson1 insp.
Rodney D Combs1 insp.
Aisha N Rashad1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hans Rudolph 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