FDA 483 - Tenderneeds Fertility LLC - December 13, 2019

Tenderneeds Fertility LLC, a reproductive HCT/Ps importer/manufacturer in Greenville, IN, was cited for numerous significant deficiencies during an FDA inspection from December 9-13, 2019. The firm failed to establish fundamental quality system procedures, including donor eligibility determination, design controls, complaint handling, MDRs, purchase controls, nonconforming product control, and CAPA. These widespread issues indicate a severe lack of basic operational and quality management systems.