Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2021-10-07.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Oct 2021 – 7 Oct 2021 | Medical Devices & Rad Health | Clean | |
| 25 Apr 2019 | Medical Devices & Rad Health | Clean | |
| 26 Jun 2014 – 30 Jun 2014 | Medical Devices & Rad Health | Clean | |
| 23 Feb 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Feb 2010
21 CFR 820.20(a)
Management ensuring quality policy is understood
Cited by Clotia C Abbey Mensah
23 Feb 2010
21 CFR 820.100(a)(5)
Changes to correct/prevent quality problems
Cited by Clotia C Abbey Mensah
Investigators
FDA investigators tied to this site in the record.
Talmane J Fisher1 insp.
Shannon A Gregory1 insp.
Patricia A Mcilroy1 insp.
Clotia C Abbey Mensah1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ademco Inc.'s 1 Form 483
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