# FDA 483 - Hospira, Inc., A Pfizer Company - March 02, 2026

Source: https://www.keypedia.com/records/483/hospira-inc-a-pfizer-company/cdd68b02-4563-45d2-a42c-0f1e0ea3ed4f

> FDA 483 for Hospira, Inc., A Pfizer Company on March 02, 2026. 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: 2026-03-02
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Hospira, Inc. in McPherson, KS, a drug product manufacturer, was inspected by the FDA from March 2-10, 2026. The inspection revealed significant deficiencies across multiple areas, including inadequate process controls for sterile drug product manufacturing, poorly designed and maintained equipment and facilities, deficient laboratory and gowning procedures, and a lack of adequate quality control unit oversight and documentation controls. These issues indicate a systemic failure to ensure drug product quality and sterility.

## 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

- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)
- [Doan N. Singh](https://www.keypedia.com/people/doan-n-singh/e52cfbca-5710-4765-8c5e-d534946b648d)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4