Naked Int'l IncSeptember 26, 2023

FDA 483 - Naked Int'l Inc - September 26, 2023

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Record Details

Naked Int'l Inc, a specification developer in Miami Beach, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked essential documentation and procedures for its condom product, including design history files, complaint handling, supplier controls, and corrective and preventive actions. These observations indicate a fundamental absence of a robust quality management system.

Company: Naked Int'l Inc
Inspection Date: September 26, 2023
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Ronald Ifraimov (investigator)

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ID · 188ffa24-4433-4c48-aaa7-eca6e8109801