Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2021-09-03.
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 |
|---|---|---|---|
| 30 Aug 2021 – 3 Sep 2021 | Medical Devices & Rad Health | Clean | |
| 4 Jan 2017 – 10 Jan 2017 | Medical Devices & Rad Health | Clean | |
| 20 Mar 2013 – 28 Mar 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Nov 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Linda Linh N Adams1 insp.
Kenya Destin1 insp.
Seema S Singh1 insp.
Mary R Hole1 insp.
Timothy C Grome1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Creganna Medical'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