# FDA 483 - Midwest Sterilization Corporation - March 22, 2018

Source: https://www.globalkeysolutions.net/records/483/midwest-sterilization-corporation/aaa969a5-677c-43c8-9979-d49cf454f215

> FDA 483 for Midwest Sterilization Corporation on March 22, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Midwest Sterilization Corporation
- Inspection Date: 2018-03-22
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Midwest Sterilization Corp. in Jackson, MO, a contract sterilizer, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions, unvalidated changes to production software, and insufficient validation of equipment calibration procedures. These issues indicate a lack of robust control over critical sterilization processes.

## Related Documents

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## Related Officers

- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.globalkeysolutions.net/companies/midwest-sterilization-corporation/dfa6fd66-8330-469e-ae25-cc70cfb645cd

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