FDA 483 - Rinovum Subsidiary 2 LLC - June 11, 2019

Rinovum Women's Health in Monroeville, PA, received a Form FDA 483 following an inspection of their medical device specification development. The inspection revealed significant deficiencies in complaint handling, corrective and preventive actions, and risk analysis for their Stork OTC device. Specifically, the firm failed to adequately investigate complaints, particularly those involving cervical cap separation requiring medical intervention, and had inadequate CAPA procedures and risk assessments for these recurring issues.