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FDA Inspection
•Pfizer Ireland Pharmaceuticals Unlimited Company•September 18, 2018

Pfizer Ireland Pharmaceuticals Unlimited Company – FDA Inspection, Sep 18, 2018

Record Details

This FDA Inspection record concerns Pfizer Ireland Pharmaceuticals Unlimited Company, with an inspection on September 18, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Pfizer Ireland Pharmaceuticals Unlimited Company
Inspection Date
September 18, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Mihaly S. Ligmond (FDA Associated Person)
  • Scott E. Norris (Company Rep)
View Company Profile

ID · 40f0696e-b593-42fb-a26d-f710df3d6a13

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1066269
FDA center
Biologics
Project area
Vaccines and Allergenic Products
Outcome
Form 483 issued

Other FDA inspections of Pfizer Ireland Pharmaceuticals Unlimited Company

12
DateClassificationOfficeProject area
December 15, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 11, 2023Not classifiedOffice of Inspections and Investigations
January 24, 2023Not classifiedOffice of Inspections and Investigations
November 12, 2019VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
November 9, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 12 other inspections on the company page
Other documents for Pfizer Ireland Pharmaceuticals Unlimited Company
  • FDA Inspection 1270977 - 2023-12-15
  • FDA Inspection 1208210 - 2023-05-11
  • FDA Inspection 1201722 - 2023-01-24
  • FDA Inspection 1109599 - 2019-11-12
  • FDA Inspection 1112255 - 2018-11-09

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