Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-03-27.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Mar 2019 – 27 Mar 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Feb 2017 – 16 Feb 2017 | Medical Devices & Rad Health | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Mar 2019
21 CFR 820.60
Identification procedures, Lack of or inadequate procedures
Cited by Jeremy L Stukes
27 Mar 2019
21 CFR 820.60
Identification procedures, Lack of or inadequate procedures
Cited by Jeremy L Stukes
Investigators
FDA investigators tied to this site in the record.
Jeremy L Stukes1 insp.
CntrctMntr YoungJD1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.60 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Unysen Health, Inc'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