Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-09-16.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Sep 2022 – 16 Sep 2022 | Medical Devices & Rad Health | Clean | |
| 6 Feb 2017 – 10 Feb 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Dec 2015 – 16 Dec 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Jun 2011 | Not recorded | 483 | View 483 → |
| 14 May 2010 | Not recorded | Clean | |
| 2 Apr 2007 | Not recorded | Clean | |
| 8 Mar 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Feb 2017
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Eric M Padgett, Edward E Lockwood
10 Feb 2017
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Eric M Padgett, Edward E Lockwood
16 Dec 2015
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Shafiq Ahadi, Karen M Montgomery
Investigators
FDA investigators tied to this site in the record.
Kelly D Sheppard2 insp.
Joseph D Gong1 insp.
Eric M Padgett1 insp.
Edward E Lockwood1 insp.
Shafiq Ahadi1 insp.
Karen M Montgomery1 insp.
Robert D Tollefsen1 insp.
James D Planchon1 insp.
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 | 6x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.200(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Elekta 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