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
quoted from http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM485237.pdf
No comments:
Post a Comment