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

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.