FDA 483 - Apollo Care, LLC - April 05, 2023

Apollo Care, LLC, an outsourcing facility in Columbia, MO, was inspected and cited for significant deficiencies in quality control, aseptic processing, and labeling. Observations included failures to investigate discrepancies, inadequate aseptic process validation, non-adherence to contamination prevention procedures, improper drug product storage, and missing required information on drug product labels and containers. This inspection also noted a repeat observation from 2018 regarding discrepancy review.