Overview
- 16 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
16
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2025 – 21 Nov 2025 | Medical Devices & Rad Health | Clean | |
| 1 Sep 2025 – 5 Sep 2025 | Human Drugs | 483 | On file |
| 6 May 2025 – 12 May 2025 | Human Drugs | Clean | |
| 4 Jun 2018 – 12 Jun 2018 | Human Drugs | 483 | On file |
| 22 Feb 2016 – 1 Mar 2016 | Human Drugs | 483 | View 483 → |
| 5 May 2014 – 14 May 2014 | Human Drugs | 483 | View 483 → |
| 29 Apr 2013 – 2 May 2013 | Medical Devices & Rad Health | Clean | |
| 27 Sep 2012 | Not recorded | Clean | |
| 13 Jan 2012 | Not recorded | 483 | On file |
| 15 Jul 2011 | Not recorded | 483 | On file |
| 18 Dec 2009 | Not recorded | 483 | View 483 → |
| 7 Nov 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Mar 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Libia M Lugo, Xiaokuang Lai
1 Mar 2016
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Libia M Lugo, Xiaokuang Lai
1 Mar 2016
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Libia M Lugo, Xiaokuang Lai
1 Mar 2016
21 CFR 314.81(b)(1)(ii)
Contamination, chemical or physical change, deterioration
Cited by Libia M Lugo, Xiaokuang Lai
Investigators
FDA investigators tied to this site in the record.
Jeffrey J Thibodeau1 insp.
Ruben C Ayala1 insp.
Xingfang Li1 insp.
MRA M BarbosaR1 insp.
Jose A Cruz Gonzalez1 insp.
Libia M Lugo1 insp.
Xiaokuang Lai1 insp.
Nadeem I Chaudhry1 insp.
Rafael E Arroyo1 insp.
Janete F Guardia1 insp.
Zachery L Miller1 insp.
Steven A Gonzales1 insp.
Andria L Kuhlman1 insp.
Jonee J Mearns1 insp.
Ernest Bizjak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Janssen Pharmaceutica, N.V.'s 7 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