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

Source: https://www.globalkeysolutions.net/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 - 2014-04-23](https://www.globalkeysolutions.net/records/eir/hospira-inc-a-pfizer-company/cb4c5e27-0aa6-4fad-8897-5754de801d5b)
- [483 - 2002-09-12](https://www.globalkeysolutions.net/records/483/hospira-inc-a-pfizer-company/2091e659-230d-47bd-892c-11d347ec23db)
- [EIR - 2017-10-27](https://www.globalkeysolutions.net/records/eir/hospira-inc-a-pfizer-company/e7115820-ea8b-4be8-a8c2-e2c3b6507f59)
- [EIR - 2011-05-25](https://www.globalkeysolutions.net/records/eir/hospira-inc-a-pfizer-company/3dabb1b6-25c7-42d3-8699-f0c34ab17fcf)
- [EIR - 2016-06-08](https://www.globalkeysolutions.net/records/eir/hospira-inc-a-pfizer-company/cbba781c-5e68-4b37-8cbd-03176aa653f2)

## Related Officers

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

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

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