Overview
- 15 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-01.
At a glance
Inspections
15
Form 483s
3
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Oct 2024 – 1 Nov 2024 | Biologics | 483 | On file |
| 5 Dec 2023 – 14 Dec 2023 | Biologics | 483 | View 483 → |
| 1 Jun 2022 – 17 Jun 2022 | Human Drugs | Clean | |
| 13 Sep 2021 – 17 Sep 2021 | Biologics | Clean | |
| 23 Jan 2017 – 26 Jan 2017 | Human Drugs | Clean | |
| 14 Jan 2016 – 22 Jan 2016 | Human Drugs | Clean | |
| 16 May 2013 – 21 May 2013 | Human Drugs | Clean | |
| 19 Jun 2012 | Not recorded | Clean | |
| 22 Aug 2011 | Not recorded | Clean | |
| 6 Aug 2010 | Not recorded | Clean | |
| 15 Jan 2009 | Not recorded | 483 | On file |
| 7 Feb 2008 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Dec 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Thai D Truong, Laurel A Beer
14 Dec 2023
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Thai D Truong, Laurel A Beer
Investigators
FDA investigators tied to this site in the record.
Paul L Bellamy5 insp.
Michael Serrano2 insp.
Xiuju Lu1 insp.
Carl A Perez1 insp.
Kevin J Matthews1 insp.
Thai D Truong1 insp.
Laurel A Beer1 insp.
Frederick Razzaghi1 insp.
Jacqueline M Diaz Albert1 insp.
Graeme E Price1 insp.
Lily Y Koo1 insp.
David E Bailey1 insp.
Zhaohui Ye1 insp.
Jacqueline M Diaz Albertini1 insp.
Atul Agrawal1 insp.
Amy M Cramer1 insp.
Joy R Klena1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.14(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Janssen Pharmaceuticals Inc.'s 3 Form 483s
Source PDFs 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