Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-17.
At a glance
Inspections
7
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jan 2025 – 17 Jan 2025 | Human Drugs | Clean | |
| 16 Sep 2024 – 24 Sep 2024 | Human Drugs | Clean | |
| 18 Jun 2018 – 22 Jun 2018 | Human Drugs | Clean | |
| 4 Feb 2016 – 25 Feb 2016 | Human Drugs | 483 | View 483 → |
| 19 Nov 2015 – 24 Nov 2015 | Human Drugs | Clean | |
| 14 Apr 2011 | Not recorded | 483 | View 483 → |
| 2 Oct 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Feb 2016
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Craig D Zagata, Matthew R Noonan
25 Feb 2016
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Craig D Zagata, Matthew R Noonan
Investigators
FDA investigators tied to this site in the record.
Joseph L Despins2 insp.
Craig D Zagata2 insp.
Matthew R Noonan2 insp.
Sam Pepe1 insp.
Stephanie C Mangigian1 insp.
Gabrielle J Swain1 insp.
Hala L Selby1 insp.
Vlada Matusovsky1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Janssen Biotech Inc.'s 3 Form 483s
Source PDFs, 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