# FDA 483 - Hospira, Inc. - November 21, 2019

Source: https://www.keypedia.com/records/483/hospira-inc/e86d25f7-dbfb-46b3-a9cc-424f1d165750

> FDA 483 for Hospira, Inc. on November 21, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hospira, Inc.
- Inspection Date: 2019-11-21
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Hospira a Pfizer Company in Rocky Mount, NC, a sterile injectable manufacturer, revealed significant deficiencies in laboratory controls and quality system investigations. Observations included inadequate sampling plans for bacterial endotoxin testing, failure to thoroughly review bioburden and environmental monitoring excursions, and incomplete investigation records lacking conclusions and follow-up actions. These issues suggest a lack of robust quality oversight in critical manufacturing and quality control processes.

## Related Documents

- [483 - 2011-06-17](https://www.keypedia.com/records/483/hospira-inc/82896c82-4b42-450b-bb14-c9eb1b79cac1)
- [483 - 2010-01-19](https://www.keypedia.com/records/483/hospira-inc/3365c585-9a89-490b-8017-59eec2c09af5)
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- [483 - 2012-07-26](https://www.keypedia.com/records/483/hospira-inc/ecb9d0a0-1284-4b8c-89ac-f3ce4b72c2cb)

## Related Officers

- [Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/adam-r-cooke/337c005d-e9dc-4512-aadb-ee0b0c637bd5)
- [Gideon N Enzour](https://www.keypedia.com/people/gideon-n-enzour/506b8f4f-6b09-4734-b125-cc7a6f4bd038)
- [Investigator](https://www.keypedia.com/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)

Company: https://www.keypedia.com/companies/hospira-inc/d4decc1e-4b42-43bb-be2c-abcefbc7b965

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7