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

Source: https://www.keypedia.com/records/483/naked-intl-inc/188ffa24-4433-4c48-aaa7-eca6e8109801

> FDA 483 for Naked Int'l Inc on September 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Naked Int'l Inc
- Inspection Date: 2023-09-26
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/naked-intl-inc/faa5299a-389f-4371-8fc4-caf5df747a11

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