Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-06-16.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jun 2022 – 16 Jun 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Aug 2018 – 23 Aug 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 May 2015 – 15 May 2015 | Medical Devices & Rad Health | Clean | |
| 15 Apr 2013 – 22 Apr 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 May 2012 | Not recorded | 483 | View 483 → |
| 27 Aug 2010 | Not recorded | Clean | |
| 27 Jun 2007 | Not recorded | Clean | |
| 16 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jun 2022
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Stephen R Souza, Terri E Gibson
16 Jun 2022
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Stephen R Souza, Terri E Gibson
16 Jun 2022
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Stephen R Souza, Terri E Gibson
Investigators
FDA investigators tied to this site in the record.
Stephen R Souza2 insp.
Sharon I Gundersen2 insp.
Terri E Gibson1 insp.
Cynthia L Gorveatt1 insp.
Graham N Giesen1 insp.
Bryce E Mansfield1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind InBios International, Inc.'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