6 Observations in Sharp Drug FDA-483

FDA has released the FDA-483 issued following a 7/10-7/13 inspection at Sharp Drugs, a West Hampton Beach, NY, producer of sterile and non-sterile drugs. The inspection observations were: 

•          ISO 5 classified aseptic processing area located within a non-classified room (segregated production area);
•          disinfecting agents, cleaning pads, and cleaning wipes used in the ISO 5 classified area were not sterile;
•          personnel engaged in aseptic processing wear non-sterile gloves;
•          media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations;
•          materials or supplies were not disinfected prior to entering the aseptic processing area; and
•       environmental monitoring was not performed in aseptic processing areas.