# FDA 483 - Pfizer, Inc. - June 28, 2017

Source: https://www.globalkeysolutions.net/records/483/pfizer-inc/1ad4d5af-dd46-4315-a2dc-263813c484b9

> FDA 483 for Pfizer, Inc. on June 28, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer, Inc.
- Inspection Date: 2017-06-28
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: 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.

## Related Documents

- [483 - 2012-02-24](https://www.globalkeysolutions.net/records/483/pfizer-inc/2d1999d2-ecfe-406d-90bf-dbe562faac81)
- [483 - 2017-06-07](https://www.globalkeysolutions.net/records/483/pfizer-inc/fc6a7f17-be61-4cda-870c-c279ac5d2447)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.globalkeysolutions.net/companies/pfizer-inc/4b87fbf2-bec7-4fde-adf0-4207cd7d93ff

Office: https://www.globalkeysolutions.net/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94