FDA Sends Warning Letters to Florida Compounders to Assess Operations

The FDA is urging two Florida compounders to reassess their operations after finding significant issues with GMPs and sterile drug practices during inspections.

Management needs to review facility design, procedures, personnel, processes, materials and systems, according to a Feb. 4 warning letter to Orlando-based Olympia Compounding Pharmacy and a Feb. 3 warning to Myerlee Pharmacy in Fort Myers. The reviews should pay particular attention to aseptic processing, the letters say, adding that a third-party consultant may be helpful.

The letter to Olympia cites a November 2014 inspection during which employees were seen processing sterile drug products in a laminar flow hood that was not turned on and passing materials over open vials.

During the December 2014 inspection at Myerlee, the FDA also made observations on personnel practices. The investigator noted an operator with exposed forearms, as well as operators resting their forearms inside laminar flow hoods during aseptic processing of sterile drug products. In addition, personnel did not sanitize certain component bags before placing them inside clean areas.