Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-01-08.
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 |
|---|---|---|---|
| 6 Jan 2020 – 8 Jan 2020 | Medical Devices & Rad Health | Clean | |
| 11 Jun 2018 – 5 Jul 2018 | Medical Devices & Rad Health | WL | View 483 → |
| 22 Apr 2013 – 26 Apr 2013 | Medical Devices & Rad Health | 483 | On file |
| 14 Jan 2010 | Not recorded | Clean | |
| 15 Feb 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Roy Baby1 insp.
William H Shackelford1 insp.
Iris C Macinnes1 insp.
Daniel S Fam1 insp.
Cntrctmntr Rodriguez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind OriGen Biomedical, Inc.'s 2 Form 483s
Source PDFs 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