Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-11.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2026 – 11 Feb 2026 | Human Drugs | 483 | View 483 → |
| 26 Oct 2021 – 23 Nov 2021 | Human Drugs | 483 | On file |
| 24 Jul 2017 – 7 Aug 2017 | Human Drugs | 483 | On file |
| 4 Aug 2015 – 11 Aug 2015 | Human Drugs | Clean | |
| 10 Oct 2013 – 23 Oct 2013 | Human Drugs | Clean | |
| 18 Feb 2011 | Not recorded | Clean | |
| 21 Feb 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Feb 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Raquel Gonzalez Rivera, Marian E Ramirez, Yoriann M Cabrera Bartolomei
11 Feb 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Raquel Gonzalez Rivera, Marian E Ramirez, Yoriann M Cabrera Bartolomei
Investigators
FDA investigators tied to this site in the record.
Marian E Ramirez2 insp.
Jose E Melendez2 insp.
Libia M Lugo2 insp.
Raquel Gonzalez Rivera1 insp.
Yoriann M Cabrera Bartolomei1 insp.
Miguel A Martinez1 insp.
Patric C Klotzbuecher1 insp.
Robert J Martin1 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 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Janssen Cilag Manufacturing LLC'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