# FDA 483 - Innoveix Pharmaceuticals Inc - May 27, 2021

Source: https://www.keypedia.com/records/483/innoveix-pharmaceuticals-inc/5eb3fb7b-e1ce-4cd5-9fdf-dae65148670d

> FDA 483 for Innoveix Pharmaceuticals Inc on May 27, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Innoveix Pharmaceuticals Inc
- Inspection Date: 2021-05-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Innoveix Pharmaceuticals Inc. in Addison, TX, was inspected from May 11-27, 2021, and received a Form FDA 483 with nine observations. The inspection revealed significant deficiencies in aseptic processing, sterilization, and cleaning procedures for sterile injectable drug products, including the use of non-pharmaceutical grade materials and inadequate environmental controls. These issues indicate a high risk of product contamination and compromise of sterility assurance.

## Related Documents

- [483 - 2019-09-12](https://www.keypedia.com/records/483/innoveix-pharmaceuticals-inc/cbe6fa47-afc2-4fa3-8695-7e4fcfb0f23b)
- [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/708dc870-be1a-41d1-85c8-6dbd9973451a)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab