FDA 483 - Total Vein Pharmacy - May 09, 2019

Total Vein Pharmacy LLC dba Total Vein Pharmacy in Houston, TX, a producer of sterile and non-sterile drugs, was cited for three observations during an FDA inspection. The observations relate to deficiencies in the certification of ISO 5 classified areas, inadequate media fill simulations for aseptic production, and unsubstantiated contact times for disinfectants used in the ISO 5 area. These issues indicate concerns with environmental control and aseptic processing procedures.