FDANews
The QMN Weekly Bulletin

Compounder Missed Marks for Sterile Drug Processing

Oct. 6, 2017

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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