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Compounder Missed Marks for Sterile Drug Processing
Pharmaceuticals Inspections and Audits
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.