FDA 483 - ImprimisRx CA, Inc., dba ImprimisRx - March 31, 2017

ImprimisRx CA, Inc., dba ImprimisRx in Irvine, CA, was cited for three observations during an FDA inspection concerning sterile drug production. Deficiencies included inadequate aseptic processing area controls with compromised air quality, insufficient complaint record investigations and follow-up, and a quality control unit lacking full authority to investigate errors. These issues indicate significant concerns regarding the firm's quality systems and sterile drug production.