# FDA 483 - Midwest Sterilization Corporation - November 07, 2018

Source: https://www.globalkeysolutions.net/records/483/midwest-sterilization-corporation/897be239-fa71-48a0-bc23-1234633a4923

> FDA 483 for Midwest Sterilization Corporation on November 07, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Midwest Sterilization Corporation
- Inspection Date: 2018-11-07
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Midwest Sterilization Corp, a contract sterilizer in Jackson, MO, received a Form 483 with three observations. The inspection revealed significant deficiencies in their corrective and preventive action (CAPA) procedures, including issues with supplier approval and effectiveness monitoring. Additionally, the firm lacked adequate procedures for the disposition of nonconforming product and for ensuring purchased products and services conform to specified requirements.

## Related Documents

- [483 - 2018-03-22](https://www.globalkeysolutions.net/records/483/midwest-sterilization-corporation/aaa969a5-677c-43c8-9979-d49cf454f215)
- [483 - 2021-09-02](https://www.globalkeysolutions.net/records/483/midwest-sterilization-corporation/74f4b114-de97-4147-8add-45bea9386227)
- [483 - 2024-02-16](https://www.globalkeysolutions.net/records/483/midwest-sterilization-corporation/a5ef3f5a-d57d-4769-9511-b8a377af7ae1)

## Related Officers

- [Mary A. Millner](https://www.globalkeysolutions.net/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

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