Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-09-13.
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 |
|---|---|---|---|
| 12 Sep 2018 – 13 Sep 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Jun 2016 – 7 Jul 2016 | Medical Devices & Rad Health | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Sep 2018
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Roy Baby, Jamie M Bumpas
13 Sep 2018
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Roy Baby, Jamie M Bumpas
13 Sep 2018
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Roy Baby, Jamie M Bumpas
13 Sep 2018
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Roy Baby, Jamie M Bumpas
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 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Simpro's 2 Form 483s
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