FDA 483 - Tolmar, Inc. - January 31, 2023

Tolmar, Inc. in Fort Collins, CO, was cited for failing to thoroughly review unexplained discrepancies, specifically regarding repeated mold colony excursions in manufacturing rooms for their product Eligard. This is a serious repeat observation, indicating a persistent issue with the firm's investigation processes, including a lack of root cause analysis and corrective actions for environmental monitoring failures.