FDA 483 - Invitrx Therapeutics - September 18, 2019

An FDA inspection of Invitrx Therapeutics in San Juan, PR, from September 13-18, 2019, revealed multiple significant deficiencies in their manufacturing of umbilical cord blood products. Key issues included inadequate environmental monitoring, lack of validated aseptic processes, insufficient employee training, and incomplete batch production records. These observations indicate a failure to maintain proper control over critical manufacturing operations, potentially impacting product quality and sterility.