Pharmakon Long Term Care Pharmacy, Inc. – FDA 483, May 11, 2016

The FDA Form 483 details multiple deficiencies in aseptic processing and quality control. Environmental monitoring is not performed daily in critical areas; non-viable particulate monitoring is performed (b)(4), active viable air monitoring every (b)(4), passive air monitoring every (b)(4), viable surface monitoring every (b)(4), and personnel fingertip monitoring for (b)(4) (b)(4). Environmental monitoring excursions are not investigated, and an anteroom certification on (b)(4) showed 8 CFUs, exceeding the ISO (b)(4) action level of (b)(4) CFU/m. The incubator for media fill and environmental samples lacks qualification documentation, and its thermometer calibration is undocumented.

Personnel gowning for aseptic operations is inadequate; gowns, masks, shoe covers, and hair nets are not sterile, and facial/neck skin and personal clothing remain exposed. An operator was observed straightening a sterile glove with an ungloved hand. Aseptic practices are deficient, with an operator using a gowned elbow/forearm to activate a door mechanism, then contacting the ISO 5 laminar flow hood work surface with the same gowned area.

Cleaning and disinfection procedures are deficient. (b)(4) cleaning with sterile (b)(4) is not documented for all operational days, and non-sterile sanitizing agents are used. An operator was observed (b)(4) sterile (b)(4) and resuming operations before it dried. Pressure differentials