# FDA 483 - SpecialEyes,  LLC - March 28, 2024

Source: https://www.globalkeysolutions.net/records/483/specialeyes-llc/50b3c057-bafa-4f61-9c19-363ca75da221

> FDA 483 for SpecialEyes,  LLC on March 28, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SpecialEyes,  LLC
- Inspection Date: 2024-03-28
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of SpecialEyes, LLC in Sarasota, FL, revealed significant deficiencies in the firm's complaint handling and corrective and preventive action (CAPA) procedures. The company failed to process complaints uniformly and timely, adequately investigate them, or establish proper CAPA for identified issues, indicating a lack of robust quality system controls.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/specialeyes-llc/e3322e64-0959-41c0-a746-33b4b5462a6c

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