Atlas

FDA-Inspected Site

Sunrise Pharmaceutical, Inc.

12 FDA inspections are on record for Sunrise Pharmaceutical, Inc. in Rahway, United States.

483· Form 483 issued

Rahway, United States · Last updated July 9, 2026

Overview

  • 12 FDA inspections are on record.
  • 10 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-31.

At a glance

Inspections

12

Form 483s

10

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Mar 2026 – 31 Mar 2026Human Drugs483View 483 →
23 Jan 2023 – 27 Jan 2023Human DrugsClean
9 Jan 2018 – 18 Jan 2018Human Drugs483View 483 →
19 Jun 2017 – 22 Jun 2017Human Drugs483On file
22 Mar 2017 – 6 Apr 2017Human DrugsClean
12 Dec 2013 – 8 Jan 2014Human Drugs483View 483 →
4 Oct 2011Not recorded483View 483 →
20 Dec 2010Not recorded483View 483 →
17 Jul 2009Not recordedWLView 483 →
20 Aug 2007Not recorded483On file
22 Feb 2007Not recorded483On file
19 Sep 2006Not recorded483On file

Observations on record

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

31 Mar 2026
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Alisha B Patel

18 Jan 2018
21 CFR 211.25(a)

GMP Training Frequency

Cited by Yvesna C Blaise

8 Jan 2014
21 CFR 211.110(c)

In-process materials characteristics testing

Cited by Maria Estrella, Nicholas A Violand

8 Jan 2014
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Maria Estrella, Nicholas A Violand

4 Oct 2011
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Maria Estrella, Nicholas A Violand, Lisa M Bellows

Investigators

FDA investigators tied to this site in the record.

Maria Estrella3 insp.
Nicholas A Violand2 insp.
Addam S Reynolds2 insp.
Alisha B Patel1 insp.
Helen Verdel1 insp.
Yvesna C Blaise1 insp.
Zhongren Wu1 insp.
Jogy George1 insp.
Nancy M Espinal1 insp.
Lisa M Bellows1 insp.
Barbara J Wilimczyk-Macri1 insp.
Atul Agrawal1 insp.
Joseph F Mcginnis1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.110(c)Cited across public-safe Form 483 observations1x
21 CFR 211.115(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(b)Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Sunrise Pharmaceutical, Inc.'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