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Pfizer Ireland Pharmaceuticals Unlimited Company, Dublin, Ireland – FDA Inspections

Inspection records and compliance data for Pfizer Ireland Pharmaceuticals Unlimited Company in Dublin. 13 FDA inspections on record, 3 Form 483s, last inspected December 15, 2023.

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Company Profile

This profile covers Pfizer Ireland Pharmaceuticals Unlimited Company based in Dublin, Ireland.

FDA Inspection History

FDA inspections
13
OAI
0
VAI
10
NAI
1
Unclassified
2
Form 483s
3
Warning letters
0

First inspected April 24, 2009. Last inspected December 15, 2023.

Most cited issue areas

  • Deviations from laboratory control requirements1 inspection
  • Investigations of discrepancies, failures1 inspection
  • Who must report - manufacturer1 inspection

FDA inspections (13)

DateResultFDA center(s)Insp. #
December 15, 2023VAIHuman Drugs · Drug Quality Assurance1270977
May 11, 2023Not classifiedHuman Drugs1208210
January 24, 2023Not classifiedBiologics1201722
November 12, 2019VAIBiologics · Vaccines and Allergenic Products1109599
November 9, 2018VAIHuman Drugs · Drug Quality Assurance1112255
September 18, 2018VAIBiologics · Vaccines and Allergenic Products1066269
March 10, 2017VAIHuman Drugs · Drug Quality Assurance1007326
September 20, 2016VAIBiologics · Vaccines and Allergenic Products990473
June 17, 2014VAIBiologics · Vaccines and Allergenic Products895020
October 15, 2013NAIHuman Drugs · Drug Quality Assurance857677
June 28, 2012VAIBiologics · Vaccines and Allergenic Products790692
August 31, 2010VAIBiologics · Vaccines and Allergenic Products684564
April 24, 2009VAIHuman Drugs · Drug Quality Assurance581044
FDA documents

Form 483s (3)

  • Form 483s · May 11, 2023
  • Form 483s · November 12, 2019
  • Form 483s · September 10, 2018

EIRs (1)

  • EIRs · November 12, 2019
People (3)
Scott E. Norris
Person
Mihaly S. Ligmond
Person
Valerie Hanley
Person
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Company Information

Name

Pfizer Ireland Pharmaceuticals Unlimited Company

FEI Number

3004145594

Address

Grange Castle Business Park, Nangor Road, Dublin, Ireland

Country

Ireland

ID: 095513de-fb4d-4c57-847c-bef3a3b235f4

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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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