# FDA 483 - Midwest Sterilization Corporation - January 12, 2023

Source: https://www.globalkeysolutions.net/records/483/midwest-sterilization-corporation/1f838d26-38c7-48f4-8076-fc48ab7bd859

> FDA 483 for Midwest Sterilization Corporation on January 12, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Midwest Sterilization Corporation
- Inspection Date: 2023-01-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Midwest Sterilization Corporation, a contract sterilizer of medical devices in Laredo, TX, received a Form FDA 483 for significant quality system deficiencies. The inspection revealed inadequate procedures for corrective and preventive actions, including the handling of biological indicator failures and changes to sterilization processes. Additionally, the firm failed to adequately establish procedures for routine equipment calibration, specifically concerning concentration and temperature sensors in its sterilization chambers.

## Related Documents

- [483 - 2024-03-21](https://www.globalkeysolutions.net/records/483/midwest-sterilization-corporation/1cc30fac-fc5b-41c7-b3cd-52b8533d4de7)

## Related Officers

- [Katlin N. Stubbs](https://www.globalkeysolutions.net/people/katlin-n-stubbs/27d70db1-a2e9-4254-a721-c6de655f7626)
- [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/a20d46de-2469-4448-bab8-c778c7ecb863

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab