Compounder Warned for Not Cleaning Equipment
The FDA warned a Georgia-based compounder and repackager for poor cleaning practices that apparently led to patients becoming infected by contaminated products.
The agency inspected Clinical Specialties Compounding Pharmacy’s Augusta, Ga., facility in 2013, after five patients contracted a bacterial eye infection following treatment of Genentech’s cancer drug Avastin (bevacizumab), which is used to treat age-related macular degeneration as an off-label use. All of the cases were tied to two lots of Avastin repackaged at Clinical Specialties, the FDA said in a warning letter released recently.
Investigators found that Clinical Specialties did not use any sporicidal cleaning agent as part of its disinfection for the clean room. The compounder also did not sanitize equipment or supplies before placing them into the clean room.
“Failure to adequately clean and disinfect equipment and supplies exposes products being aseptically manipulated in the [clean room] area to a potential source of contamination,” says the June 27 letter.
The company agreed to recall the affected Avastin lots, and later all of its products, and stopped making sterile drugs at the facility.
Clinical Specialties did not return a request for comment as of press time.
To read the warning letter, visit www.fdanews.com/10-02-14-ClinicalSpecialtiesWarning.pdf. — Robert King