Atlas

FDA-Inspected Site

West-Ward Pharmaceuticals Corp.

18 FDA inspections are on record for West-Ward Pharmaceuticals Corp. in Eatontown, United States.

Clean· No action indicated

Eatontown, United States · Last updated July 10, 2026

Overview

  • 18 FDA inspections are on record.
  • 9 inspections produced a Form 483.
  • The most recent recorded inspection date is 2019-02-01.

At a glance

Inspections

18

Form 483s

9

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
29 Jan 2019 – 1 Feb 2019Human DrugsClean
9 Apr 2018 – 13 Apr 2018Human DrugsClean
27 Jun 2016 – 7 Jul 2016Human DrugsClean
20 Aug 2015 – 10 Sep 2015Human DrugsClean
4 Feb 2014 – 26 Feb 2014Human Drugs483View 483 →
29 Apr 2013 – 7 Jun 2013Human Drugs483On file
28 Aug 2012Not recorded483On file
30 Jun 2011Not recorded483View 483 →
25 Mar 2011Not recorded483View 483 →
17 Feb 2011Not recorded483View 483 →
1 Jun 2010Not recordedWL
1 Mar 2010Not recorded483View 483 →

Observations on record

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

26 Feb 2014
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Paul L Bellamy, Lauren L Vajo, Stephen J Mottola

30 Jun 2011
21 CFR 211.63

Equipment Design, Size and Location

Cited by Paul C Mouris, Addam S Reynolds

30 Jun 2011
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Paul C Mouris, Addam S Reynolds

30 Jun 2011
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Paul C Mouris, Addam S Reynolds

30 Jun 2011
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Paul C Mouris, Addam S Reynolds

Investigators

FDA investigators tied to this site in the record.

Addam S Reynolds7 insp.
Paul L Bellamy3 insp.
Lauren L Vajo3 insp.
Peter R Lenahan1 insp.
James R Birkenstamm1 insp.
Nicholas A Violand1 insp.
Maria Estrella1 insp.
Stephen J Mottola1 insp.
Michael R Klapal1 insp.
Paul C Mouris1 insp.
Frederick Razzaghi1 insp.
Atul Agrawal1 insp.
Russell J Glapion1 insp.
Meredith L Sheridan1 insp.
Daniel J Grabicki1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations4x
21 CFR 211.110(a)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.122(b)Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind West-Ward Pharmaceuticals Corp.'s 9 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