CURALLAX LLCApril 17, 2019

FDA 483 - CURALLAX LLC - April 17, 2019

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Record Details

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.

Company: CURALLAX LLC
Inspection Date: April 17, 2019
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Ashley A. Mutawakkil

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ID · d3f75c21-ab49-4642-a4b7-bce12dcf5d55