Home Infusions Solutions, Inc. – FDA 483, May 21, 2013

The FDA Form 483 details significant deficiencies in a facility manufacturing, processing, packing, or holding drug products, particularly sterile injectables.

**Facility and Operations:** * The building lacks suitable size, construction, and location for proper operations. Plastic flap dividers with large gaps separate the warehouse from the anteroom, and the anteroom from the clean room (housing ISO 5 Laminar Flow Hoods and a biological safety cabinet). * Cleaning buckets were observed directly adjacent to the clean room's plastic flap divider. * There is no designated gowning area for personnel entering the clean room. * Warehouse employees moved uncontrolled between the warehouse and anteroom, contacting components staged for the clean room.

**Quality System and Manufacturing Issues:** * **Contamination Control:** Deficient control systems to prevent contamination. No cleaning studies were performed to assure the suitability and effectiveness of the disinfectant used for spore, fungi, and bacterial removal in core sterile injectable processing areas. No recovery studies or challenges were performed to assure its effectiveness. * **Environmental Monitoring:** No viable air samples for fungi or bacteria were taken during ISO 5 Laminar Flow Hood (LFHs P2, P6, P7) and Biological Safety Cabinet (P4) qualifications in September 2012. No surface samples for bacteria or fungi were obtained for critical areas inside LFHs, BSC, critical contact areas, or equipment in ISO 5 areas during qualifications