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•United States

Wyeth Pharmaceutical Division of Wyeth Holdings LLC, Pearl River, NY – FDA Inspections

Inspection records and compliance data for Wyeth Pharmaceutical Division of Wyeth Holdings LLC in Pearl River, New York. 8 FDA inspections on record, 2 Form 483s, last inspected December 17, 2025.

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Company Profile

This profile covers Wyeth Pharmaceutical Division of Wyeth Holdings LLC based in Pearl River, New York, United States.

FDA Inspection History

FDA inspections
8
OAI
0
VAI
5
NAI
2
Unclassified
1
Form 483s
2
Warning letters
0

First inspected October 8, 2008. Last inspected December 17, 2025.

Most cited issue areas

  • Laboratory Test Method Verification1 inspection
  • Microbiological Contamination Exam1 inspection
  • Representative Samples Criteria1 inspection

FDA inspections (8)

DateResultFDA center(s)Insp. #
December 17, 2025VAIHuman Drugs · Drug Quality Assurance1295786
August 28, 2024VAIHuman Drugs · Drug Quality Assurance1237528
April 13, 2022VAIHuman Drugs · Drug Quality Assurance1168201
March 17, 2017Not classifiedHuman Drugs1011662
October 24, 2012VAIBiologics · Vaccines and Allergenic Products804865
July 18, 2012NAIFoods & Cosmetics · Foodborne Biological Hazards791692
July 1, 2009NAIBiologics · Bioresearch Monitoring597355
October 8, 2008VAIFoods & Cosmetics · Food Composition, Standards, Labeling and Econ539529
FDA documents

Form 483s (4)

  • Form 483s · December 17, 2025
  • Form 483s · April 13, 2022
  • Form 483s · March 17, 2017
  • Form 483s · October 8, 2008
Other regulators (1)
  • UK MHRA · 2 inspections · last December 10, 2018
People (5)
Jacqueline S. Warner
Person
Charles Jewell
Person
Antonino Ayalarian
Person
Kristina L. Conroy
Person
Lata C. Mathew
Person
Related Companies (10)

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Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Symbiosis Pharmaceutical Services Limited
Janssen Biotech, Inc.
SpecGx LLC
Regeneron Pharmaceuticals Inc
KBI Biopharma, Inc.
Avista Pharma Solutions, Inc. dba Cambrex
Company Information

Name

Wyeth Pharmaceutical Division of Wyeth Holdings LLC

FEI Number

2410662

Address

401 N Middletown Rd, Pearl River, New York 10965, United States

Country

United States

ID: 85fd73c7-1b97-4ac5-bc70-53dfb31c37e5

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