Thrifty White Drug #762 – FDA 483, Sep 21, 2018

On September 10-21, 2018, the FDA inspected Thrifty White Drug #762, a producer of sterile and non-sterile drug products, located at 6055 Nathan Ln N Ste 200A, Minneapolis, MN 55442-1675. The inspection identified six observations.

Observation 1 noted that sporicidal agents were not used in the facility's cleanrooms or ISO 5 aseptic processing area. Specifically, on September 10, 2018, daily cleaning of the ISO 5 area used only L _ (6) (4)1, and no sporicidal agent was used in the [(l5) (4J cleaning.

Observation 2 stated that disinfecting agents and cleaning wipes used in the ISO 5 aseptic processing areas were not sterile. On September 10, 2018, an employee cleaned the ISO 5 area with (6r{4} and non-sterile wipes before aseptic processing.

Observation 3 indicated that equipment and materials were not disinfected prior to entering aseptic processing areas. Items were sprayed with -(15r(4 } in a non-classified area, transported to a non-classified (6) (4 ~area leading to the ISO 7 buffer, and then placed into the ISO 5 aseptic processing area without further disinfection.

Observation 4 highlighted that the ISO