# FDA 483 - Black Pearl Vision - April 11, 2024

Source: https://www.globalkeysolutions.net/records/483/black-pearl-vision/1c85742b-8677-4c27-b295-bec28d1f1106

> FDA 483 for Black Pearl Vision on April 11, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Black Pearl Vision
- Inspection Date: 2024-04-11
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Black Pearl Vision in Sarasota, FL, identified a significant issue regarding the firm's corrective and preventive action (CAPA) system. The firm failed to adequately document CAPA activities, specifically not performing or documenting reviews of open CAPAs according to their established procedures. This indicates a lapse in quality system management related to CAPA oversight.

## Related Documents

- [483 - 2020-02-28](https://www.globalkeysolutions.net/records/483/black-pearl-vision/40c90020-1735-41be-a712-3880ba8b4f5d)

## Related Officers

- [Alex J. Wild](https://www.globalkeysolutions.net/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

Company: https://www.globalkeysolutions.net/companies/black-pearl-vision/fe19e885-814b-4f78-8490-4a37133faa19

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