Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-07-17.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jul 2026 – 17 Jul 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Jun 2022 – 1 Jul 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Apr 2018 – 20 Apr 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Sep 2016 – 15 Sep 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Mar 2013 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jul 2026
ISO 13485:2016 Clause 7.4.1
Records of supplier (re)evaluation, selection, and monitoring not maintained
Cited by Sarah A Hassas
17 Jul 2026
ISO 13485:2016 Clause 7.5.6
Records of validation of processes and necessary actions not maintained
Cited by Sarah A Hassas
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.120(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind iCRco, 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