# FDA 483 - Pfizer, Inc. - February 24, 2012

Source: https://www.globalkeysolutions.net/records/483/pfizer-inc/2d1999d2-ecfe-406d-90bf-dbe562faac81

> FDA 483 for Pfizer, Inc. on February 24, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer, Inc.
- Inspection Date: 2012-02-24
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Pfizer Laboratories, Div. Pfizer Inc. in Groton, CT, was inspected and cited for deficiencies related to equipment cleaning and maintenance procedures. Specifically, the firm failed to establish adequate written procedures for stability chamber qualification, maintenance, and impact assessments following equipment failures. These issues indicate a lack of control over critical environmental conditions for drug product stability testing.

## Related Documents

- [483 - 2017-06-07](https://www.globalkeysolutions.net/records/483/pfizer-inc/fc6a7f17-be61-4cda-870c-c279ac5d2447)
- [483 - 2017-06-28](https://www.globalkeysolutions.net/records/483/pfizer-inc/1ad4d5af-dd46-4315-a2dc-263813c484b9)

## Related Officers

- [Assuring that quality medicines are available to the American public](https://www.globalkeysolutions.net/people/maya-m-davis/4180239e-5b21-4f9c-9ff0-6bbe5222f740)

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