Atlas

FDA-Inspected Site

Janssen Ortho LLC

15 FDA inspections are on record for Janssen Ortho LLC in Manati, United States.

Clean· No action indicated

Manati, United States · Last updated July 9, 2026

Overview

  • 15 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2019-04-25.

At a glance

Inspections

15

Form 483s

6

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Apr 2019 – 25 Apr 2019Human DrugsClean
2 May 2017 – 12 May 2017Human DrugsClean
1 Feb 2016 – 11 Feb 2016Human Drugs483On file
27 Jun 2014 – 3 Jul 2014Human DrugsClean
5 May 2014 – 23 May 2014Human Drugs483View 483 →
29 Jun 2012Not recorded483View 483 →
28 Jun 2010Not recorded483View 483 →
11 May 2009Not recorded483On file
17 Jul 2008Not recorded483On file
12 Mar 2007Not recordedClean
10 May 2006Not recordedClean
13 Apr 2005Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

23 May 2014
21 CFR 211.67(b)(2)

Cleaning SOPs/schedules

Cited by Libia M Lugo

23 May 2014
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Libia M Lugo

23 May 2014
21 CFR 211.192

Written record of investigation incomplete

Cited by Libia M Lugo

23 May 2014
21 CFR 314.81(b)(1)(ii)

Failure to meet specifications

Cited by Libia M Lugo

29 Jun 2012
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Noreen Muniz

Investigators

FDA investigators tied to this site in the record.

Marian E Ramirez2 insp.
Noreen Muniz2 insp.
Joan M Cantellops Figueroa1 insp.
Frances L Dejesus1 insp.
Jose F Velez1 insp.
Libia M Lugo1 insp.
Jose R Lopez1 insp.
Dayna I Martinez1 insp.
Jose A Cruz Gonzalez1 insp.
Javier O Vega1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Janssen Ortho LLC's 6 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