Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-04-03.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Mar 2023 – 3 Apr 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Aug 2018 – 8 Aug 2018 | Medical Devices & Rad Health | Clean | |
| 9 Dec 2014 – 11 Dec 2014 | Medical Devices & Rad Health | Clean | |
| 9 Dec 2014 – 10 Dec 2014 | Medical Devices & Rad Health | Clean | |
| 6 Dec 2011 | Not recorded | 483 | View 483 → |
| 16 Sep 2009 | Not recorded | Clean | |
| 24 Oct 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Dec 2011
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Casey L Hamblin, Jessica Stephens
6 Dec 2011
21 CFR 820.70(i)
Software validation for automated processes
Cited by Casey L Hamblin, Jessica Stephens
Investigators
FDA investigators tied to this site in the record.
Andrew Saunders2 insp.
Shirhonda D Thorn2 insp.
Nikki S Bryant1 insp.
Babatunde D Babalola1 insp.
Marquis S Allen1 insp.
Casey L Hamblin1 insp.
Jessica Stephens1 insp.
Karl D Hezel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(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 Odyssey Medical Technologies, LLC.'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