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FDA Inspection
•Pfizer, Inc.•June 3, 2009

Pfizer, Inc. – FDA Inspection, Jun 3, 2009

Record Details

This FDA Inspection record concerns Pfizer, Inc., with an inspection on June 3, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Pfizer, Inc.
Inspection Date
June 3, 2009
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 00481e63-972f-48ea-a27e-33c20d91d791

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
586238
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

4
  1. 21 CFR 312.50General responsibilities of sponsors
  2. 21 CFR 312.50Ensuring compliance with plan and protocol
  3. 21 CFR 312.53(a)Investigator selection
  4. 21 CFR 312.53(d)Selecting monitors

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Pfizer, Inc.

25
DateClassificationOfficeProject area
October 24, 2025Not classifiedNew England District Office
December 13, 2024VAINew England District OfficeBioresearch Monitoring: Human Drugs
August 30, 2024Not classifiedNew England District Office
July 19, 2024Not classifiedNew England District Office
April 19, 2023NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
View all 25 other inspections on the company page
Other documents for Pfizer, Inc.
  • FDA Inspection 1284680 - 2025-10-24
  • FDA Inspection 1256477 - 2024-12-13
  • FDA Inspection 1249289 - 2024-08-30
  • FDA Inspection 1230476 - 2024-07-19
  • FDA Inspection 1204434 - 2023-04-19

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