FDA 483 - Reprolife America, LLC - March 20, 2026

Reprolife America, LLC in Kingwood, TX, a medical device manufacturer, received a Form FDA 483 with 10 observations during an inspection from March 16-20, 2026. The inspection revealed widespread deficiencies in the firm's quality management system, including a lack of documented procedures for design control, process validation, risk management, complaint handling, traceability, and corrective actions. These systemic failures indicate a significant lack of control over the manufacturing of Vitrification Solution Sets and Warning Solution Sets, potentially impacting product quality and safety.