# FDA 483 - Hospira, Inc., A Pfizer Company - June 30, 2023

Source: https://www.keypedia.com/records/483/hospira-inc-a-pfizer-company/b5f34599-a21b-4d1e-a587-4d0b84148ab9

> FDA 483 for Hospira, Inc., A Pfizer Company on June 30, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hospira, Inc., A Pfizer Company
- Inspection Date: 2023-06-30
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Hospira Inc., A Pfizer Company in Mcpherson, KS, identified a significant issue related to the prevention of microbiological contamination in sterile drug products. The inspection observed apparent leaks in the (b) (4) system on two separate occasions, indicating a failure to establish and follow appropriate written procedures. These findings suggest potential risks to the sterility of drug products manufactured at the facility.

## Related Documents

- [EIR - 2009-08-27](https://www.keypedia.com/records/eir/hospira-inc-a-pfizer-company/92a6d26a-2257-4847-af32-519195412bff)
- [483 - 2020-01-17](https://www.keypedia.com/records/483/hospira-inc-a-pfizer-company/5fd1ec23-950b-45fe-af59-cd16ba28bd6e)
- [483 - 2016-06-08](https://www.keypedia.com/records/483/hospira-inc-a-pfizer-company/1c8df434-1558-4219-8df9-297e94f070e8)
- [EIR - 2012-05-25](https://www.keypedia.com/records/eir/hospira-inc-a-pfizer-company/e15bd57a-7f1b-4a24-bcf7-97f066aae6f5)
- [EIR - 2015-04-03](https://www.keypedia.com/records/eir/hospira-inc-a-pfizer-company/e0e214f5-ef5b-4a27-8fa0-f80aee0844e0)

## Related Officers

- [Damaris Y. Hernandez](https://www.keypedia.com/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)
- [Matthew M. Schuckmann](https://www.keypedia.com/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)

Company: https://www.keypedia.com/companies/hospira-inc-a-pfizer-company/46d63c80-caf7-40db-8325-13fcade5e82c

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8