Compounder Missed Marks for Sterile Drug Processing

An Alabama compounding pharmacy fell short of several standards for sterile drug processing, the FDA said in a Form 483 inspection report.

Included among the findings at the pharmacy, Triad Rx, in Daphne, were:

• Pads or wipes used to clean an isolation area were not sterile;
• Equipment that was difficult to clean or visibly dirty was located in designated sterile areas, specifically a lyophilizer and a dehumidifier;
• Workers touched equipment or surfaces with gloved hands outside the sterile workspaces and then processed sterile products inside those workspaces without changing or sanitizing their gloves;
• Workers processing sterile products with hands, wrists, legs, hair or mouths exposed; and
• A pump used in sterile processing was not properly disinfected.