# FDA 483 - Best Image Optical, Inc. - March 09, 2023

Source: https://www.globalkeysolutions.net/records/483/best-image-optical-inc/ac1572a5-620b-43a3-b474-b1b9f9451fab

> FDA 483 for Best Image Optical, Inc. on March 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Best Image Optical, Inc.
- Inspection Date: 2023-03-09
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Best Image Optical, Inc. in Doral, FL, a specification developer, was inspected by the FDA. The inspection revealed significant deficiencies across its quality system, with a complete lack of established procedures for critical areas such as Medical Device Reporting, complaint handling, corrective and preventive actions, and quality audits. These findings indicate a fundamental failure to implement essential regulatory requirements for medical device manufacturers.

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Company: https://www.globalkeysolutions.net/companies/best-image-optical-inc/bc33c5de-0270-4dc1-88b9-7caa9992678f

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