FDA 483 - GSK Vaccines GmbH - November 12, 2024

**FDA 483 Summary for GSK Vaccines GmbH**

**Company Name:** GSK Vaccines GmbH **Inspection Dates:** November 4-12, 2024 **Location:** Marburg, Hesse, Germany **Inspection Conducted By:** FDA's Division of Manufacturing and Product Quality

**Main Violations/Issues:**

1. **Facility and Equipment Maintenance:** The inspection revealed significant deficiencies in the maintenance of facilities and equipment used in the production of Shingrix and Measles bulk drug substances. Specific issues included leaking liquids, residue accumulation, discoloration, and deterioration in classified areas.

2. **Critical Utilities:** Utilities critical to the production of Shingrix were found to be inadequately qualified and monitored. Quality control testing was not consistently performed, and a comprehensive monitoring program was absent.

3. **Quality Oversight and Data Integrity:** There were lapses in the oversight and integrity of electronic data systems supporting manufacturing processes. Missing documentation, unexplained aborted tests, and insufficient quality oversight of testing procedures were noted.

**Regulatory Framework:** The observations fall under the regulatory oversight of the FDA, which requires adherence to Good Manufacturing Practices (GMP) to ensure product quality and safety.

**Required Actions:**

- **Corrective Maintenance:** Immediate action is required to address the maintenance issues of facilities and equipment to prevent contamination and ensure product integrity. - **Utility Qualification and Monitoring:** Establish and implement a robust qualification and monitoring program for critical utilities to ensure consistent quality. - **Enhance Quality Oversight:** Improve quality oversight mechanisms and ensure the integrity of electronic data systems by addressing documentation gaps and ensuring comprehensive testing protocols.

These observations are preliminary and do not represent a final determination of compliance. GSK Vaccines GmbH is expected to address these issues promptly and provide corrective action plans to the FDA.