FDA 483 - Invitrx Therapeutics Inc. - April 30, 2025

An FDA inspection of Invitrx Therapeutics Inc. in Lake Forest, CA, revealed significant deficiencies in their manufacturing of human blood HCT/Ps. The firm failed to establish and follow critical procedures for donor eligibility, product release, manufacturing controls, and quality programs. These issues indicate a high risk of releasing unsafe or non-compliant products due to inadequate controls, record-keeping, and equipment maintenance.