FDA 483 - Healix Infusion Therapy, Inc. - September 14, 2016

This FDA Form 483 was issued to Healix Infusion Therapy Inc., a producer of sterile drugs located at 1075 W Park One Dr Ste 200, Sugar Land, TX 77478-2576. The inspection was conducted from September 1, 2016, to September 14, 2016, by Investigator Stephen D Brown. The report was issued to Mark G. Winters, Chief Operating Officer and Vice-President of Operations.

The sole observation noted was a deficiency in the aseptic processing areas regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Specifically, the firm was observed utilizing two non-sterile disinfectants, [redacted] and [redacted], in the ISO 5 areas. This indicates a potential issue with maintaining the required sterile environment for drug production.