# FDA 483 - ULTRAVISION CORPORATION - May 20, 2022

Source: https://www.globalkeysolutions.net/records/483/ultravision-corporation/1c4927b3-4925-4633-adc2-9a61d76d52e6

> FDA 483 for ULTRAVISION CORPORATION on May 20, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ULTRAVISION CORPORATION
- Inspection Date: 2022-05-20
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of ULTRAVISION CORPORATION in North Palm Beach, FL, revealed significant deficiencies across its quality system. The firm failed to establish adequate procedures for design control, quality audits, management review, training, MDR reporting, complaint handling, and purchasing controls. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ultravision-corporation/0677acfd-6e94-4a9c-8565-acb0ae231b2f

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