Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-03-11.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Mar 2016 – 11 Mar 2016 | Medical Devices & Rad Health | Clean | |
| 11 Dec 2013 – 13 Dec 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Jan 2012 | Not recorded | Clean | |
| 28 Dec 2009 | Not recorded | 483 | View 483 → |
| 23 Apr 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Dec 2009
21 CFR 820.80(c)
Lack of or inadequate In-process acceptance procedures
Cited by Sargum C Sood
Investigators
FDA investigators tied to this site in the record.
Amy S Graf1 insp.
Tracey L Siebesma1 insp.
Gary D Urbiel Goldner1 insp.
Sargum C Sood1 insp.
Gregory A Cronce1 insp.
Anastasia M Piliafas-Brown1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Graham Medical Technologies, L.L.C.'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