Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-12-14.
At a glance
Inspections
9
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Dec 2018 – 14 Dec 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 May 2018 – 16 May 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Mar 2015 – 12 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 5 Sep 2012 | Not recorded | Clean | |
| 29 Jul 2011 | Not recorded | 483 | View 483 → |
| 20 Jul 2010 | Not recorded | Clean | |
| 24 Nov 2009 | Not recorded | 483 | View 483 → |
| 13 Feb 2006 | Not recorded | Clean | |
| 9 May 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Dec 2018
21 CFR 812.43(c)(5)
No financial disclosure info in investigator agreement
Cited by Stephanie C Mangigian, Kelly N Kerr
14 Dec 2018
21 CFR 812.46(a)
Sponsor securing investigator compliance
Cited by Stephanie C Mangigian, Kelly N Kerr
14 Dec 2018
21 CFR 812.40
Sponsors' general responsibilities
Cited by Stephanie C Mangigian, Kelly N Kerr
Investigators
FDA investigators tied to this site in the record.
Don A Leeseberg2 insp.
Jeffrey R Wooley2 insp.
Stephanie C Mangigian1 insp.
Kelly N Kerr1 insp.
Joshua J Silvestri1 insp.
Elisa M Fleming1 insp.
Akbar J Zaidi1 insp.
Saijal Naik1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.43(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.46(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | 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 Erchonia Corporation, LLC's 4 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