Sterility concerns and other deficiencies at a Maryland drugmaker could be putting patients at risk, the FDA told Option Care Enterprises in Columbia, Md. in a July 20 warning letter.
Option Care’s sterility practices are in violation of federal standards and law, according to the letter, including use of non-sterile wipes and disinfectants being used to clean what is supposed to be an aseptic drug processing area. Technicians were observed handling trash and then returning to work without sanitizing or changing their gloves or gown, and cleanroom hoods were coated in rust and residues, investigators observed.
The agency also notes the company’s media fills “do not closely simulate aseptic production operations, including worst-case activities,” which means Option Care’s products may be produced “in an environment that poses a significant contamination risk.”