FDA 483 - Innoveix Pharmaceuticals Inc - September 12, 2019

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