The QMN Weekly Bulletin
Pharmaceuticals / Inspections and Audits

Compounder Missed Marks for Sterile Drug Processing

Oct. 6, 2017
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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.

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