FDA 483 - Tenderneeds Fertility LLC - September 29, 2021

Tenderneeds Fertility LLC in Greenville, IN, was inspected by the FDA, resulting in seven observations highlighting a severe lack of fundamental quality system procedures. The firm failed to establish and maintain procedures for design control, complaint handling, design history files, MDRs, purchase control, nonconforming product, and corrective and preventive actions. Many of these deficiencies were noted as repeat observations, indicating systemic issues in meeting regulatory requirements for medical device manufacturing.