Overview
- 14 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-28.
At a glance
Inspections
14
Form 483s
10
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Mar 2023 – 28 Mar 2023 | Human Drugs | 483 | View 483 → |
| 6 Aug 2018 – 28 Aug 2018 | Human Drugs | 483 | View 483 → |
| 15 May 2017 – 26 May 2017 | Human Drugs | 483 | View 483 → |
| 11 May 2016 – 18 May 2016 | Human Drugs | 483 | View 483 → |
| 22 Feb 2016 – 26 Feb 2016 | Human Drugs | 483 | On file |
| 26 May 2015 – 29 May 2015 | Human Drugs | 483 | View 483 → |
| 17 Jan 2013 – 22 Feb 2013 | Human Drugs | 483 | View 483 → |
| 13 Jun 2011 | Not recorded | 483 | View 483 → |
| 2 Sep 2010 | Not recorded | Clean | |
| 8 Jun 2009 | Not recorded | 483 | On file |
| 21 Feb 2008 | Not recorded | 483 | On file |
| 15 Jun 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Mar 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Raquel Gonzalez Rivera, Jose F Velez, Angelica M Hernandez
28 Mar 2023
21 CFR 211.22(a)
Approve or reject components, products
Cited by Raquel Gonzalez Rivera, Jose F Velez, Angelica M Hernandez
28 Mar 2023
21 CFR 211.65(a)
Equipment construction - reactive surfaces
Cited by Raquel Gonzalez Rivera, Jose F Velez, Angelica M Hernandez
28 Aug 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Libia M Lugo, Raquel Gonzalez Rivera
28 Aug 2018
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Libia M Lugo, Raquel Gonzalez Rivera
Investigators
FDA investigators tied to this site in the record.
Raquel Gonzalez Rivera2 insp.
Libia M Lugo2 insp.
Noreen Muniz2 insp.
Laurimer Kuilan-Torres2 insp.
Jose E Melendez2 insp.
Jose F Velez1 insp.
Angelica M Hernandez1 insp.
Jose A Lopez Rubet1 insp.
Jose A Moreno1 insp.
Christina A Capacci-Daniel1 insp.
Arwa S El Hagrasy1 insp.
Dennis Cantellops Paite1 insp.
Vilmary Negron Rodriguez1 insp.
Ariel Cruz Figueroa1 insp.
Binh T Nguyen1 insp.
Ramon A Hernandez1 insp.
Rebecca Rodriguez1 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 | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | 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 Ortho LLC's 10 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