FDA 483 - Allegheny Health Network Home Infusion, LLC - December 05, 2014

During an FDA inspection, multiple deficiencies were observed in the compounding and aseptic processing of sterile injectable products.

**Facility and Operations:** * Production of Total Parenteral Nutrition (TPN) was observed in an ISO 6 Compounding Room instead of ISO 5 conditions, with opened ampoules exposed. * Components were staged in a manner requiring technicians to extend over opened ampoules. * The TPN workbench and Chemo Biological Safety Cabinet lacked proper ISO 5 qualification through airflow studies (smoke studies) under static and dynamic conditions. * Technicians moved freely in the ISO 6 area without restriction, and the demarcation between ISO 5 and ISO 6 was unclear.

**Violations and Quality System Issues:** * **Aseptic Technique Deficiencies:** * Vigorous shaking of product after diluent addition was observed. * Frequent contact with non-sterile components/surfaces (door handle, trash bag, scissors, packaging) without sanitizing gloved hands with sterile 70% isopropyl alcohol. * Reusing a single sanitizing sterile pad multiple times on opened vials and sterile connections, even after rewetting. * Applying non-sterile hand rub to sterile gloves. * Immediately wiping gloved hands with non-sterile wipes after sanitizing, not allowing sufficient contact time for isopropyl alcohol. * Picking up trash from the floor and immediately resuming