FDA EIR - Merck Teknika LLC - February 23, 2022

An FDA inspection of Merck Teknika LLC, a licensed gene therapy manufacturer in Durham, NC, was conducted from February 15-23, 2022. This Level 2 GMP inspection, performed under CP 7345.848 for biological drug products, focused on the manufacturing of Bacillus Calmette-Guerin (BCG) drug substance. Although no formal Form FDA 483 observations were issued during this inspection, the report detailed several significant concerns discussed with management, primarily related to the firm's environmental monitoring program. The investigator questioned the appropriateness of action and alert limits for fungi in classified areas, noting they were identical to bacteria limits. Concerns were also raised regarding personnel monitoring limits, suggesting a cumulative contamination approach might be more effective. Furthermore, the absence of a smoke study in a Grade D room after a structural defect was identified posed a potential risk to airflow without proper assessment. Management acknowledged these concerns, stating they would take them under advisement. The inspection also reviewed corrective actions for a ten-item FDA 483 issued in January 2020. While documentation indicated updates, visual verification of implemented corrections for certain observations could not be performed, as the facility was not actively manufacturing. This visual verification is recommended for the next FDA inspection.