Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-09-14.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2014 – 14 Sep 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Aug 2012 | Not recorded | 483 | On file |
| 12 May 2010 | Not recorded | Clean | |
| 11 Feb 2009 | Not recorded | Clean | |
| 19 Mar 2008 | Not recorded | Clean | |
| 2 Dec 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Sep 2014
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Katherine E Jacobitz, Durell L Giles
14 Sep 2014
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Katherine E Jacobitz, Durell L Giles
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 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pfm Medical Inc'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