# FDA 483 - Fettech - July 14, 2023

Source: https://www.globalkeysolutions.net/records/483/fettech/53461477-0e82-4e38-a6ba-f58992e3a188

> FDA 483 for Fettech on July 14, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fettech
- Inspection Date: 2023-07-14
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Fettech, a manufacturer in Davie, FL, was inspected by the FDA from July 11-14, 2023. The inspection revealed a significant issue regarding internal quality audits, specifically that individuals with direct responsibility for audited matters were conducting the audits. This indicates a lack of independence in the audit process.

## Related Officers

- [David M. Wilkinson](https://www.globalkeysolutions.net/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)

Company: https://www.globalkeysolutions.net/companies/fettech/c0f3a2f5-d032-4c6c-8389-066f9e8e6c76

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6