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

Source: https://www.keypedia.com/records/483/heartland-home-infusions-inc-dba-hhi-infusion-services/05fe490b-4619-4f76-8c14-88a94e03fbc6

> FDA 483 for Heartland Home Infusions, Inc. dba HHI Infusion Services on July 27, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Heartland Home Infusions, Inc. dba HHI Infusion Services
- Inspection Date: 2017-07-27
- Product Type: Drugs
- Office Name: Chicago District Office
- Summary: 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,

## Related Officers

- [Senior Compliance Manager](https://www.keypedia.com/people/christina-a-miller/7893b145-2814-4443-a886-29881db45918)

Company: https://www.keypedia.com/companies/heartland-home-infusions-inc-dba-hhi-infusion-services/980d6945-4035-4ee4-acc4-863bbc05aa9d

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669