Two Compounders Hit With Warning Letters

Two compounders are facing FDA warning letters for sterility concerns, with one company being pummeled for numerous other quality deficiencies.

FDA inspectors noted that Complete Pharmacy and Medical Solutions failed to use effective sporicidal agents as part of its disinfection programs for the clean room and ISO 5 area. During an August 2014 inspection, investigators noted that the Miami Lakes, Fla.-based company did not have adequate procedures to sterilize and depyrogenate glass vials and rubber stoppers.

An August 2015 inspection of Bedford Pharmacy found the company did not use a sporicidal agent or sterile wipes in its disinfection program for its aseptic processing area.