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

Source: https://www.keypedia.com/records/483/healix-infusion-therapy-inc/7eb2c8f4-5f5e-4094-b67b-1ac048ed40fb

> FDA 483 for Healix Infusion Therapy, Inc. on September 14, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Healix Infusion Therapy, Inc.
- Inspection Date: 2016-09-14
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: 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.

## Related Documents

- [483 - 2014-05-16](https://www.keypedia.com/records/483/healix-infusion-therapy-inc/9874029c-7534-45fb-9f61-8741e9635352)
- [STATE_REFERRAL_LETTER - 2016-09-07](https://www.keypedia.com/records/state_referral_letter/healix-infusion-therapy-inc/0c2ad7a7-f8c6-4ad3-a100-da9ed02f42bd)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)

Company: https://www.keypedia.com/companies/healix-infusion-therapy-inc/848e6e7c-088d-4353-a1d5-f3bf0f414152

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9