FDA 483 - Tri-Med, Inc. dba Advanced Care Infusion-Shelby - July 11, 2017

During an FDA inspection on July 11, 2017, the firm was cited for four observations related to aseptic processing and environmental controls, all of which were repeat observations from a previous FDA 483 issued on February 23, 2015.

Observation 1 noted that disinfecting agents and cleaning wipes used in aseptic processing areas were not sterile. Specifically, non-sterile disinfectant and wipes were used to sanitize Lioresal 2000MCG/ML (2X20ML) SYRINGE ampules and a box prior to transfer into the ISO 5 hood, with no additional sanitization. These non-sterile wipes were also used within the ISO 5 hood.

Observation 2 detailed inadequate aseptic techniques by personnel during the processing of Lioresal 2000MCG/ML (2X20ML) SYRINGE. Issues included a technician wearing non-sterile gloves during ISO 5 hood sanitization, returning to the ISO 5 hood without sanitizing gloves after retrieving materials, donning sterile gloves non-aseptically over non-sterile gloves, non-sterile gown sleeves contacting the ISO 5 hood surface, and non-deliberate hand movements within the ISO 5 hood.

Observation 3 stated that equipment, materials, and supplies were not disinfected prior to entering aseptic processing areas. Components were wiped with non-sterile disinfectant by a technician wearing non-sterile gloves and then