# FDA 483 - F & A Foundation - May 09, 2025

Source: https://www.keypedia.com/records/483/f-a-foundation/cffe0a5f-2c77-47b9-9ed5-49b96c7886d1

> FDA 483 for F & A Foundation on May 09, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: F & A Foundation
- Inspection Date: 2025-05-09
- Product Type: device
- Office Name: Dallas District Office
- Summary: F & A Foundation, a class II medical device manufacturer in Tulsa, OK, was cited for multiple quality system deficiencies during an FDA inspection. The firm lacked adequate procedures for design validation, design change control, and managing nonconforming products. Additionally, issues were noted with supplier control and the submission of required information to the Global Unique Device Identification Database (GUDID).

## Related Officers

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Company: https://www.keypedia.com/companies/f-a-foundation/fe176a84-dafe-42b1-bc35-20b8dcff4893

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