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

Invitrx Therapeutics Inc., an HCT/P manufacturer in Lake Forest, CA, was cited for significant deficiencies across its operations. The inspection revealed widespread failures in donor eligibility determination, manufacturing procedures, quality control, record keeping, and equipment maintenance. These issues indicate a severe lack of control over critical processes, posing risks to product safety and integrity.