FDA 483 - GenoGenix, LLC - July 18, 2025

**FDA 483 Summary: GenoGenix LLC Inspection**

**Company:** GenoGenix LLC **Inspection Dates:** July 14-18, 2025 **Location:** Boca Raton, FL **Type of Establishment:** Outsourcing Facility

**Key Violations/Issues:**

1. **Microbiological Contamination Prevention:** Procedures to prevent contamination in sterile drug products were inadequate. Observations included visible contaminants in sterile injectable drugs and improper aseptic techniques by technicians.

2. **Quality Control Unit (QU) Oversight:** The QU lacked written procedures and failed to oversee critical processes, including release specifications, sterility assurance, and environmental monitoring. There was no established sterility assurance program for injectable drugs.

3. **Aseptic Process and Personnel Monitoring:** The firm did not conduct media fills, gowning qualifications, or personnel monitoring for compounding technicians. Smoke studies and testing for non-sterile bulk solutions were also not performed.

4. **Documentation and Control Procedures:** The QU did not establish essential procedures such as master batch records, change controls, corrective actions, and stability study programs. There was a lack of control over drug product release, recalls, and employee training.

**Regulatory Framework:** The inspection was conducted under the regulatory framework governing outsourcing facilities, focusing on compliance with current Good Manufacturing Practices (cGMP).

**Required Actions:** GenoGenix LLC must address the observed deficiencies by implementing corrective actions, including establishing comprehensive quality control procedures, ensuring proper aseptic techniques, and maintaining thorough documentation and training programs. The firm is advised to communicate any objections or corrective actions to the FDA promptly.

This summary outlines critical compliance issues identified during the FDA inspection, necessitating immediate attention to ensure product safety and regulatory adherence.