FDA 483 - Apollo Renal Therapeutics, LLC - September 11, 2019

An FDA inspection of Apollo Renal Therapeutics, LLC, a medical device contract manufacturer in Ocala, FL, revealed significant deficiencies in their quality system. Observations included inadequate process validation for medical products, undocumented equipment calibrations, and poorly established procedures for handling complaints and corrective and preventive actions. These issues indicate a need for comprehensive improvements in their manufacturing and quality control processes.