483
Pfizer Inc.Pfizer Inc. – FDA 483, Dec 13, 2024
Record Details
An FDA inspection of Pfizer Inc.'s nonclinical laboratory in Groton, CT, revealed two significant observations. The firm failed to conduct nonclinical laboratory studies in accordance with the established protocol, specifically regarding dose administration and animal termination dates. Additionally, the study director did not ensure that all raw data and documentation, including email correspondence, were properly transferred to the archives at the close of a study.
View Company Profile
ID · 0a8f268c-7a50-424d-b28d-4f771fa8db04
Other documents for Pfizer Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.