FDA 483 - BioIntegrate Inc - July 18, 2023

BioIntegrate Inc, a relabeler/manufacturer in Morrow, GA, was inspected by the FDA from July 10-18, 2023. The inspection revealed significant deficiencies in quality control, including failure to test drug products before release, inadequate investigations into discrepancies, and improper donor eligibility determinations for HCT/P products. The firm also lacked proper labeling controls, batch production records, stability data for expiration dates, annual product reviews, and reserve sample procedures, indicating a broad lack of adherence to good manufacturing practices.