# FDA 483 - Hospira, Inc. - November 14, 2023

Source: https://www.keypedia.com/records/483/hospira-inc/5c3e063a-836d-4935-b609-0dea69d3e704

> FDA 483 for Hospira, Inc. on November 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hospira, Inc.
- Inspection Date: 2023-11-14
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Hospira, Inc. in Rocky Mount, NC, revealed significant deficiencies in laboratory controls and product testing. The firm lacked adequate analytical methods to detect unknown impurities in drug products manufactured on shared equipment, including highly potent drugs. Additionally, Hospira failed to perform container closure integrity testing as part of its release criteria, raising concerns about product sterility and quality.

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## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

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