# FDA 483 - CURALLAX LLC - April 17, 2019

Source: https://www.globalkeysolutions.net/records/483/curallax-llc/d3f75c21-ab49-4642-a4b7-bce12dcf5d55

> FDA 483 for CURALLAX LLC on April 17, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CURALLAX LLC
- Inspection Date: 2019-04-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Capillus LLC, a manufacturer of laser devices in Doral, FL, received an FDA Form 483 with five observations, many of which were repeats. The inspection revealed failures in submitting required product and supplemental reports for their Capillus devices. Additionally, the firm was cited for issues with product certification labels, identification labels lacking manufacturing dates, and improper reproduction of warning logotype labels in marketing materials.

## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

Company: https://www.globalkeysolutions.net/companies/curallax-llc/3b34bff1-b04e-407d-b872-763d34e20103

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