# FDA 483 - Hospira, Inc., A Pfizer Company - August 30, 2007

Source: https://www.globalkeysolutions.net/records/483/hospira-inc-a-pfizer-company/acd9dab9-3306-4219-9c00-ed95526edfd8

> FDA 483 for Hospira, Inc., A Pfizer Company on August 30, 2007. 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: 2007-08-30
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: This FDA Form 483 was issued to Hospira, Inc. in McPherson, KS, following an inspection from August 20-30, 2007. The inspection revealed significant deficiencies in aseptic processing, including inadequate environmental monitoring, poor aseptic technique by operators, failure to follow cleaning procedures, and insufficient validation of sterilization processes. These issues indicate a high risk of microbiological contamination for sterile drug products.

## 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)
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- [EIR - 2016-06-08](https://www.globalkeysolutions.net/records/eir/hospira-inc-a-pfizer-company/cbba781c-5e68-4b37-8cbd-03176aa653f2)

## Related Officers

- [Matthew R. Sleeter](https://www.globalkeysolutions.net/people/matthew-r-sleeter/ae499ca7-a437-482e-926b-991e11613bfc)
- [Gwyn G Dickinson](https://www.globalkeysolutions.net/people/gwyn-g-dickinson/56712d29-3800-44a3-b942-b5802c124ff9)

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

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79