# FDA 483 - Hospira, Inc., A Pfizer Company - January 17, 2020

Source: https://www.globalkeysolutions.net/records/483/hospira-inc-a-pfizer-company/5fd1ec23-950b-45fe-af59-cd16ba28bd6e

> FDA 483 for Hospira, Inc., A Pfizer Company on January 17, 2020. 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: 2020-01-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: This FDA Form 483 report for Hospira Inc. in Mcpherson, KS, identifies significant deficiencies in the firm's sterile drug manufacturing processes. Repeated observations highlight persistent issues with quality control, inadequate process validation, and insufficient investigation procedures. The findings indicate a systemic lack of assurance regarding sterile drug product quality and patient safety.

## 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

- [Scott A Holliday](https://www.globalkeysolutions.net/people/scott-a-holliday/edc07888-f5e4-4869-89b1-3e92851e515f)
- [National Expert, Pharmaceutical](https://www.globalkeysolutions.net/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)
- [Program Analyst](https://www.globalkeysolutions.net/people/jazmine-n-still/92bc804f-1f4e-46f6-8802-6a65b50f91ae)

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