Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-01-25.
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 |
|---|---|---|---|
| 21 Jan 2019 – 25 Jan 2019 | Human Drugs | 483 | On file |
| 22 Apr 2016 – 29 Apr 2016 | Human Drugs | Clean | |
| 8 Sep 2014 – 11 Sep 2014 | Human Drugs | 483 | View 483 → |
| 4 Jul 2013 – 11 Jul 2013 | Human Drugs | 483 | On file |
| 21 Oct 2010 | 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.
Niketa Patel1 insp.
Steve Y Rhieu1 insp.
Michael P Sheehan1 insp.
Torrance J Slayton1 insp.
Sandra A Hughes1 insp.
Kelvin Cheung1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Janssen Cilag SpA's 3 Form 483s
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