# FDA 483 - Hospira, Inc. - August 04, 2011

Source: https://www.globalkeysolutions.net/records/483/hospira-inc/985730f5-cef4-479b-8ac8-0e7241142062

> FDA 483 for Hospira, Inc. on August 04, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hospira, Inc.
- Inspection Date: 2011-08-04
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Hospira, Inc. in Rocky Mount, NC, a sterile pharmaceutical manufacturer, was cited for significant deficiencies in its quality control and laboratory operations. The inspection revealed a failure to thoroughly investigate out-of-specification results and batch failures, leading to the release of non-conforming product lots. Additionally, the firm lacked scientifically sound test procedures, including inadequate method transfers and verifications for various drug products.

## Related Documents

- [483 - 2011-06-17](https://www.globalkeysolutions.net/records/483/hospira-inc/82896c82-4b42-450b-bb14-c9eb1b79cac1)
- [483 - 2010-01-19](https://www.globalkeysolutions.net/records/483/hospira-inc/3365c585-9a89-490b-8017-59eec2c09af5)
- [483 - 2019-11-21](https://www.globalkeysolutions.net/records/483/hospira-inc/e86d25f7-dbfb-46b3-a9cc-424f1d165750)
- [483 - 2011-08-04](https://www.globalkeysolutions.net/records/483/hospira-inc/e0d8b125-2d3c-41d0-bd52-31ea75e878f3)
- [483 - 2012-07-26](https://www.globalkeysolutions.net/records/483/hospira-inc/ecb9d0a0-1284-4b8c-89ac-f3ce4b72c2cb)

## Related Officers

- [Chemist](https://www.globalkeysolutions.net/people/daphne-santiago/8d875abe-9ff5-408d-addf-6d07d07767cf)
- [Penny H. McCarver](https://www.globalkeysolutions.net/people/penny-h-mccarver/d67e1e77-b311-440c-9537-0746284c1368)

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

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