Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2012-09-26.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Sep 2012 | Not recorded | 483 | View 483 → |
| 29 Jan 2009 | Not recorded | 483 | On file |
| 6 Oct 2008 | Not recorded | 483 | On file |
| 22 Apr 2005 | Not recorded | Clean | |
| 22 Aug 2003 | Not recorded | Clean | |
| 16 Aug 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Sep 2012
21 CFR 820.70(i)
Software validation for automated processes
Cited by James D Hildreth, Stanley B Eugene
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 820.70(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Welch Allyn Protocol, Inc's 3 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