FDA 483 - Invitrx Therapeutics Inc. - March 22, 2022

Invitrx Therapeutics Inc., a biological drug manufacturer in Lake Forest, CA, was cited for numerous significant deficiencies during an FDA inspection from March 1-22, 2022. The observations highlight severe issues across donor eligibility, aseptic processing validation, sterility testing, environmental monitoring, batch recordkeeping, stability testing, complaint handling, and component control for its human umbilical cord and foreskin fibroblast-derived products. Many of these critical violations were repeat observations, indicating a systemic lack of compliance with cGMP and cGTP requirements.