Dant Culver

Auditor Dant Culver demonstrates a thorough and meticulous approach to grasping practices of drug manufacturing facilities. His approach specifically targets sterility assurance and aseptic practices, underlining the importance of environment control in these sensitive areas. Clean room protocols, including personnel’s attire and cleaning/disinfection, are under his close surveillance.

FDA auditor Dant Culver has a strong focus on the sterility and clean room practices used during aseptic processing, the validity of stability testing, and the sufficiency of laboratory testing for batch release. He also pays significant attention to the personal hygiene and clothing of personnel working in clean rooms. He repeatedly emphasizes the need for comprehensive and accurate record-keeping and the importance of robust environmental monitoring programs. Culver's observations suggest that he is meticulous and detail-oriented in his assessments, and he expects high standards of compliance with FDA regulations.