FDA RESUME - Unknown Company

The FDA inspection resume for Marcia D. Fields outlines her professional experience and responsibilities, primarily focusing on her role as a pharmacist with the United States Public Health Service (USPHS) since January 2015. Fields operates at the largest federal prison complex in the U.S., overseeing pharmaceutical care for approximately 6,600 inmates across various security institutions. Her duties include supervising pharmacy technicians, extending services to remote facilities, ensuring compliance with clinical guidelines, and conducting drug utilization reviews. Additionally, she is involved in creating policies for controlled substances, reporting to the Pharmacy and Therapeutics Committee, and training staff on electronic health records.

Previously, Fields worked as a Product Safety Specialist at Mylan from August 2013 to January 2015. Her responsibilities included documenting adverse events related to Mylan products, ensuring compliance with global safety standards, and developing Risk Evaluation and Mitigation Strategies. She collaborated with retail pharmacy providers, provided medical information, and trained new hires in departmental procedures.

The document does not specify inspection dates or detailed violations/issues but highlights Fields' adherence to regulatory frameworks, such as the Food, Drug, and Cosmetic Act, and her role in policy development and compliance. Required actions focus on maintaining compliance, improving pharmacy services, and ensuring the safety and efficacy of pharmaceutical practices.