FDA 483 - InfuScience, Inc. dba Bioscrip Infusion Services - July 30, 2019

An FDA inspection of InfuScience, Inc. dba Bioscrip Infusion Services, a producer of sterile drug products in Chantilly, VA, was conducted from July 23-30, 2019. The inspection revealed eight observations regarding the facility's sterile drug production practices.

Observation 1 noted inadequate segregation, cleaning of work surfaces, and cleaning of utensils to prevent cross-contamination of beta-lactam drugs. Specific instances included producing a non-beta-lactam product after beta-lactam production without proper cleaning, and producing a beta-lactam product in the same ISO 5 hood as unsealed non-beta-lactam vials.

Observation 2 identified visibly dirty equipment or surfaces in ISO 5 classified aseptic processing areas, specifically "white staining" on rear HEPA filters of laminar air flow hoods, which were not cleaned before or between aseptic processing of products, including Total Parenteral Nutrition (TPN).

Observation 3 detailed personnel blocking first pass air during aseptic manipulations. This occurred when technicians manipulated sterile connections, with IV bags or equipment blocking the exposed sterile connection from first pass air in the ISO 5 classified area.

Observation 4 cited personnel not disinfecting and changing gloves frequently enough. Technicians reached into trash receptacles and touched surfaces outside the ISO 5 area without sanitizing or changing gloves before resuming aseptic processing.

Observation 5 stated that materials and supplies were not disinfected prior to entering aseptic processing areas.