FDA 483 - Healix Infusion Therapy, Inc. - May 16, 2014

Healix Infusion Therapy, Inc., an Outsourcing Facility located in Sugar Land, TX, was inspected by the FDA from May 12-16, 2014. The inspection revealed several significant observations indicating deficiencies in the company's adherence to current Good Manufacturing Practice (cGMP) for sterile drug products.

Main violations included inadequate environmental monitoring within aseptic processing areas. Specifically, the firm failed to perform daily environmental monitoring of its ISO 5 compounding area when preparing injectable drug products, and its standard operating procedures lacked defined frequencies for air and surface sampling. Additionally, operator gloves in ISO 5 and ISO 7 cleanrooms were not monitored daily during sterile drug production, with the relevant procedure lacking a specified sampling frequency.

Furthermore, procedures to prevent microbiological contamination were found deficient. Media fills, critical for verifying aseptic technique, did not adequately simulate actual production conditions or cover worst-case scenarios like operator fatigue or varying batch sizes. The company's written procedures also did not require all personnel working in ISO 5/ISO 7 areas to perform these media fills or specify their frequency.

Finally, personnel gowning for manufacturing was deemed inappropriate, as operators wore glasses that allowed exposed skin around the eyes and forehead, potentially compromising the sterile environment. Healix Infusion Therapy is expected to address these observations by implementing comprehensive corrective actions to ensure compliance and the sterility of its drug products.