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Friday, March 4, 2016

Just a few of the problems the FDA has identified during inspections of compounding pharmacies

During its inspections of compounders, FDA continues to identify serious problems at facilities that are making drugs expected or intended to be sterile. For example, FDA has seen:  the use of non-sterile drinking water dispensed from a top-loaded bottled water dispenser to make injectable drug products  dog beds, dog feces, and dog hairs within a compounding facility, including in close proximity to the compounding room  compounding of sterile drugs by personnel with exposed skin, which sheds particles and bacteria  use of coffee filters to filter particulates  toaster ovens used for sterilization  a kitchen dishwasher and detergent used to clean sterile compounding equipment and utensils  dead insects in ceilings  renovations conducted next to sterile compounding operations without taking precautions to prevent contamination of the sterile products.

quoted from http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM485237.pdf

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