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

Source: https://www.keypedia.com/records/483/innoveix-pharmaceuticals-inc/1bf0bf79-655f-44d4-8655-57ffc818ca40

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

---

## Details

- Record Type: 483
- Company Name: Innoveix Pharmaceuticals Inc
- Inspection Date: 2019-09-12
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA inspection of a facility producing sterile drug products, including Human Chorionic Gonadotropin and Sermorelin w/GHRP2, revealed multiple violations related to aseptic processing and facility design.

Key observations include:
- **Aseptic Processing Deficiencies**: Unprotected sterile drug product (Human Chorionic Gonadotropin, Lot #INX575) was exposed to air quality lower than ISO 5. Capping and crimping of sterile products occurred outside the ISO 5 biosafety cabinet in a non-classified general pharmacy area.
- **Environmental Control Failures**: The facility design allowed poor air influx into higher classified areas. There was a failure to monitor differential pressure between ISO 5 and ISO 7 I.V. Buffer areas. Third-party qualification did not include smoke studies under dynamic conditions for any classified areas (ISO 8 Anteroom, ISO 7 I.V. Buffer, ISO 5 biosafety cabinet), leading to uncharacterized unidirectional airflows. The biosafety cabinet's airflow was turned off when not in use, risking contamination. The ISO 7 I.V. Buffer room failed qualifications in 2018 and 2017 due to exceeding fungal counts. A sterility failure for Sermorelin w/GHRP2 (Lot SER125) occurred in 2016.
- **Personnel Practices**: The Pharmacist-In-Charge (PIC) touched non-aseptic surfaces

## Related Documents

- [483 - 2019-09-12](https://www.keypedia.com/records/483/innoveix-pharmaceuticals-inc/cbe6fa47-afc2-4fa3-8695-7e4fcfb0f23b)
- [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