The FDA cited a Dallas home infusion therapy pharmacy for failure to maintain sterile conditions for drugmaking after inspectors found dead insects in a cleanroom and in refrigerators used to store ingredients and finished products.
The pharmacy operates as a branch of Preferred Homecare, a home health care provider in the Southwest and West.
The agency’s Form 483 report also noted the presence of reddish-brown residue on a ventilation hood in a sterile production cleanroom. Workers improperly transferred materials into the cleanroom via a pass-through window, the report said, and they touched surfaces outside the isolation area with gloved hands and then prepared prescription medications within the area without changing or sanitizing the gloves.
Workers also used non-sterile pads or wipes for cleaning in sterile production areas, the report said.