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•United States

Allergan Sales, LLC, Irvine, CA – FDA Inspections

Inspection records and compliance data for Allergan Sales, LLC in Irvine, CA. 15 FDA inspections on record, 1 Form 483, last inspected November 07, 2025.

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Company Profile

This profile covers Allergan Sales, LLC based in Irvine, CA, United States.

FDA Inspection History

FDA inspections
15
OAI
0
VAI
3
NAI
9
Unclassified
3
Form 483s
1
Warning letters
0

First inspected July 9, 2010. Last inspected November 7, 2025.

Most cited issue areas

  • Late submission of 15-day report2 inspections
  • Late submission of annual safety reports1 inspection
  • Procedures not in writing, fully followed1 inspection

FDA inspections (15)

DateResultFDA center(s)Insp. #
November 7, 2025Not classifiedHuman Drugs1285134
September 19, 2025Not classifiedMedical Devices & Rad Health1276207
October 26, 2023Not classifiedHuman Drugs1226167
July 28, 2023NAIHuman Drugs · Drug Quality Assurance1217963
January 22, 2019NAIMedical Devices & Rad Health · Bioresearch Monitoring1077891
October 19, 2016NAIMedical Devices & Rad Health · Compliance: Devices991910
January 15, 2016VAIHuman Drugs · Bioresearch Monitoring966871
December 7, 2015NAIMedical Devices & Rad Health · Bioresearch Monitoring951257
April 15, 2014VAIHuman Drugs · Bioresearch Monitoring890000
December 23, 2013NAIHuman Drugs · Bioresearch Monitoring861076
April 2, 2013NAIHuman Drugs, Medical Devices & Rad Health · Drug Quality Assurance826803
July 3, 2012NAIHuman Drugs · Drug Quality Assurance789290
August 30, 2011NAIMedical Devices & Rad Health · Compliance: Devices741966
September 20, 2010NAIHuman Drugs, Medical Devices & Rad Health · Drug Quality Assurance681054
July 9, 2010VAIHuman Drugs · Bioresearch Monitoring671851
FDA documents

Form 483s (2)

  • Form 483s · November 7, 2025
  • Form 483s · July 9, 2010

EIRs (2)

  • EIRs · January 22, 2019
  • EIRs · December 23, 2013
People (5)
Binh T. Nguyen
Person
Diane C. Van Leeuwen
Person
Rena Pandit
Person
Naduka K. Amaratunge
Person
Elaina Hontalas
Person
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Company Information

Name

Allergan Sales, LLC

FEI Number

2011068

Address

2525 Dupont Dr., Irvine, CA 92612, United States

Country

United States

ID: 1c953156-6298-4351-8d2d-bc0fa979d4eb

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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