# FDA 483 - Chase Medical - February 25, 2021

Source: https://www.globalkeysolutions.net/records/483/chase-medical/15e30148-471f-4e26-aae5-20603240bcee

> FDA 483 for Chase Medical on February 25, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chase Medical
- Inspection Date: 2021-02-25
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of KDL Medical Inc dba Chase Medical, a device manufacturer in Richardson, TX, identified two significant observations. The firm failed to adequately validate the sterilization process for a Class I Sternal Retractor device. Additionally, the company did not implement proper statistical techniques, specifically failing to follow its established sampling plan for receiving inspection of components.

## Related Officers

- [Jennifer Cunningham](https://www.globalkeysolutions.net/people/jennifer-cunningham/5c332d60-b1e8-444f-8994-68cb1586c7eb)

Company: https://www.globalkeysolutions.net/companies/chase-medical/9cd1aa5d-6af0-4346-83fa-a460624591e8

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9