483
Pfizer, Inc.Pfizer, Inc. – FDA 483, Jun 28, 2017
Record Details
An FDA inspection of Pfizer, Inc. in Groton, CT, identified a significant issue regarding the monitoring of clinical studies. The firm failed to ensure that clinical investigators, sub-investigators, and study coordinators completed required protocol training prior to their involvement in studies. This deficiency was observed across multiple clinical sites and involved untimely identification and investigation of missing training.
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ID · 1ad4d5af-dd46-4315-a2dc-263813c484b9
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