# FDA 483 - Innoveix Pharmaceuticals Inc - September 12, 2019

Source: https://www.keypedia.com/records/483/innoveix-pharmaceuticals-inc/cbe6fa47-afc2-4fa3-8695-7e4fcfb0f23b

> FDA 483 for Innoveix Pharmaceuticals Inc on September 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Innoveix Pharmaceuticals Inc
- Inspection Date: 2019-09-12
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Innovix Pharmaceuticals Inc. in Addison, TX, was inspected regarding its production of sterile and non-sterile drug products. The inspection revealed numerous critical deficiencies in aseptic processing, environmental controls, personnel practices, and equipment sterilization, indicating a severe lack of control over sterile manufacturing operations. These issues included inadequate air quality, improper disinfection, contaminated gowning, and ineffective sterilization methods, posing significant risks to product sterility.

## Related Documents

- [483 - 2019-09-12](https://www.keypedia.com/records/483/innoveix-pharmaceuticals-inc/1bf0bf79-655f-44d4-8655-57ffc818ca40)
- [483 - 2021-05-27](https://www.keypedia.com/records/483/innoveix-pharmaceuticals-inc/5eb3fb7b-e1ce-4cd5-9fdf-dae65148670d)
- [483 - 2021-05-27](https://www.keypedia.com/records/483/innoveix-pharmaceuticals-inc/708dc870-be1a-41d1-85c8-6dbd9973451a)

## Related Officers

- [Jason R. Caballero](https://www.keypedia.com/people/jason-r-caballero/c2c8d281-0d02-459f-9541-bc04cb6d0a59)

Company: https://www.keypedia.com/companies/innoveix-pharmaceuticals-inc/c062aaf7-433f-4f53-b529-2c5f5d853924

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