Debra tends to scrutinize the production process for compliance with ANDA and pays strict attention to the accuracy and completeness of record keeping. Debra prioritizes defined hold times for products, and thorough equipment calibration. Inconsistencies and deviations in SOP adherence, equipment calibration, and process validation are key areas where Debra probes.

Debra Bennett is a detailed-oriented FDA investigator with a focus on production process, documentation, and equipment calibration. Debra has a keen interest in ensuring that manufacturing processes adhere strictly to approved guidelines. Based on historical observations, she also possesses a rigorous approach to the validation of processes, including a keen eye for uncovering inconsistencies in calibration practices and SOP adherence.