FDA 483 - Heartland Home Infusions, Inc. dba HHI Infusion Services - July 27, 2017

This FDA Form 483 was issued to Heartland Home Infusions, Inc. dba HHI Infusion Services, a producer of sterile drug products, located at 901 McClintock Drive, Suite 106, Burr Ridge, Illinois 60527. The inspection was conducted from July 6-27, 2017.

Three observations were noted:

1. **Sporicidal agents are not used in the facility's cleanrooms and/or ISO 5 area.** Specifically, the firm does not use a sporicidal agent to clean surfaces in the ISO 5 laminar flow hoods or the ISO 5 TV Room and ISO 6 Chemo Room floors, walls, and ceilings. The firm is required to use a sporicidal agent for cleaning ISO 5 laminar flow hoods after operations and work orders.

2. **Beta-lactam drugs were produced without providing adequate containment, segregation, and cleaning of work surfaces and personnel to prevent cross-contamination.** The firm produces both penicillin and other sterile human drug products in the same laminar flow hood. On July 6, 2017, a technician produced Ceftriaxone, Vancomycin, Meropenem, and Oxacillin in the same hood. The firm's cleaning practice is to only use a specific cleaning agent in the laminar flow hood between different products. On July 6, 2017,