# FDA 483 - Black Pearl Vision - February 28, 2020

Source: https://www.globalkeysolutions.net/records/483/black-pearl-vision/40c90020-1735-41be-a712-3880ba8b4f5d

> FDA 483 for Black Pearl Vision on February 28, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Black Pearl Vision
- Inspection Date: 2020-02-28
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Clerio Vision dba X-Cel Specialty Contacts, a medical device manufacturer in Sarasota, FL, was inspected by the FDA. The inspection revealed one observation concerning the lack of adequate approval for process validation activities and results. Specifically, the annual revalidation of the soft contact lens sterilization process was overdue and a deviation justification was unapproved.

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- [483 - 2024-04-11](https://www.globalkeysolutions.net/records/483/black-pearl-vision/1c85742b-8677-4c27-b295-bec28d1f1106)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

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