# FDA 483 - S&S X-Ray Products, Inc. - March 09, 2020

Source: https://www.globalkeysolutions.net/records/483/ss-x-ray-products-inc/151cc576-f0db-4534-b2b8-3e16c1f400b8

> FDA 483 for S&S X-Ray Products, Inc. on March 09, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: S&S X-Ray Products, Inc.
- Inspection Date: 2020-03-09
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Talon, a medical device manufacturer in Houston, TX, identified significant deficiencies in its quality system. The firm failed to adequately establish procedures for complaint handling, design change control, and purchasing data requirements. These issues indicate a lack of implemented controls necessary to ensure product quality and compliance.

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/ss-x-ray-products-inc/68fb4641-481c-4366-8c47-1ca54c7b555e

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