Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-06-22.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Jun 2017 – 22 Jun 2017 | Medical Devices & Rad Health | Clean | |
| 28 May 2014 – 2 Jun 2014 | Medical Devices & Rad Health | 483 | On file |
| 26 Nov 2012 | Not recorded | 483 | View 483 → |
| 24 Apr 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Nov 2012
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Brigitte K Hofmann
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 820.30(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind The Procter & Gamble Co.'s 2 Form 483s
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