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483
•Pfizer Inc.•May 8, 2009

Pfizer Inc. – FDA 483, May 8, 2009

Record Details

Groton Laboratories, Pfizer Inc. in Groton, CT, received a Form FDA 483 following an inspection of its non-clinical laboratory. The inspection revealed issues related to the accurate recording and verification of experimental data, including dose formulation details and storage documentation. Additionally, the final study reports failed to accurately specify the storage locations for all specimens.

Company
Pfizer Inc.
Inspection date
May 8, 2009
Product type
drugs
Office
FDA District Office — Stoneham, Massachusetts
People
  • M. Patricia Murphy (investigator)
  • John A. Kadavil (investigator)
  • Anthony N. Onianwa (Investigator)
  • Abhijit Raha (other)
View Company Profile

ID · a46c9db1-8b85-4598-a0ce-dcca3b22933e

Other documents for Pfizer Inc.
  • 483 - 2024-12-13December 13, 2024
  • EIR - 2021-01-08January 8, 2021
  • EIR - 2018-11-02November 2, 2018
  • EIR - 2018-07-18July 18, 2018
  • EIR - 2018-06-21June 21, 2018

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