# FDA 483 - Powers Medical Devices, LLC - April 29, 2022

Source: https://www.keypedia.com/records/483/powers-medical-devices-llc/d44f9994-1c38-44e7-8281-f484bc85d7b5

> FDA 483 for Powers Medical Devices, LLC on April 29, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Powers Medical Devices, LLC
- Inspection Date: 2022-04-29
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Powers Medical Devices, LLC, a medical device manufacturer in Stuart, FL, was cited with three repeat observations during an FDA inspection. The firm failed to perform internal quality audits, adequately establish and implement corrective and preventive action procedures, and ensure purchased products and services conform to requirements through supplier audits. These repeat findings indicate persistent deficiencies in the firm's quality system.

## Related Officers

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

Company: https://www.keypedia.com/companies/powers-medical-devices-llc/bdd0efe7-cd80-433b-b2ff-03237e452425

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