Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-08.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 May 2025 – 8 May 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Nov 2022 – 18 Nov 2022 | Medical Devices & Rad Health | Clean | |
| 10 Apr 2019 – 12 Apr 2019 | Medical Devices & Rad Health | Clean | |
| 22 Apr 2014 – 24 Apr 2014 | Medical Devices & Rad Health | 483 | On file |
| 15 Sep 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 May 2025
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Stephen D Eich
Investigators
FDA investigators tied to this site in the record.
Stephen D Eich1 insp.
Felix J Marrero1 insp.
Shaquenta Y Perkins1 insp.
Jocelyn C Turner1 insp.
Selene T Torres1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cenova AB's 3 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