# FDA 483 - The Feminina Group, Inc. - May 09, 2025

Source: https://www.keypedia.com/records/483/the-feminina-group-inc/a44e81a5-3cf6-4e14-b350-189f95989628

> FDA 483 for The Feminina Group, Inc. on May 09, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Feminina Group, Inc.
- Inspection Date: 2025-05-09
- Product Type: device
- Office Name: Seattle District Office
- Summary: The Femina Group, Inc. in Seattle, WA, was inspected and cited for numerous significant deficiencies across its quality system for medical devices. The inspection revealed a pervasive lack of established procedures for critical areas such as Medical Device Reporting, design control, complaint handling, corrective and preventive actions, and quality audits. These findings indicate a fundamental failure to implement and maintain a compliant quality system for their Class II device, gennev Comfort Moisture.

## Related Officers

- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.keypedia.com/companies/the-feminina-group-inc/b2ad9ba9-deb6-4447-b8b9-4b64fa7e7a5d

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913