New England Home Therapies, Inc – FDA 483, Sep 24, 2014

This FDA Form 483 details multiple deficiencies observed during an inspection.

**Personnel and Facility:** * Cleanroom operators' attire was inappropriate; non-sterile gowns/coveralls, face masks, hair bonnets, and goggles/glasses were used or improperly worn. Operators used non-sterile hand antiseptic before and after donning sterile gloves. Gowns touched the floor during donning. * The ante room sink, used for handwashing, was leaking from the pipe.

**Aseptic Processing and Environmental Control:** * The firm lacked cleaning efficacy studies for disinfectants used in ISOS zones, cleanroom, and ante room. * A sporicidal agent was not routinely used for ISOS hoods. * Non-sterile wipers were used for disinfection in ISOS zones and equipment, with no information on non-shedding properties. * Environmental monitoring (viable and non-viable particulates) was not conducted during aseptic processing in ISO 5 zones. * Personnel monitoring was not conducted daily after aseptic processing/cleanroom exit, and did not include forearms, forehead, chest, or goggles/glasses. * Molds/yeasts for work surface monitoring were not incubated at the manufacturer's recommended 20-25°C.

**Product Testing and Contamination Prevention:** * Injectable finished drug products were not tested for assay or sterility prior to release. * The firm processed