Lakecha N. Lewis, Steward
Lakecha serves as an Investigator for the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS). She is directly employed within the Office of Bioresearch Monitoring Inspectorate (OBMI) and specializes in conducting investigations around the world as a subject matter expert within the OBMI Foreign Cadre. She serves as a Union Steward in Region 9 (San Francisco), which includes Arizona, California, Hawaii, Nevada, the Pacific Territories, and over 150 Native American Tribes. She is skilled at oral and written communications, enabling members to advocate for themselves with clear and concise statements of fact.
Her federal work involves clinical research, which determines the safety and efficacy of drugs, medical devices, blood products, and other medical necessities, in humans and animals. She has held this role for over six years, and has been employed with the FDA for nearly 18 years. During the COVID-19 pandemic, she worked tirelessly, traveling to research facilities all over the world to ensure that FDA requirements were met to grant Emergency Use Authorizations, and to ensure that vaccines were demonstrably safe and effective prior to distribution and administration.
Previously, Lakecha worked as Level 2-Certified Clinical Bioresearch Monitoring Specialist within FDA, where she conducted inspections both domestically and overseas. She has performed over 300 inspections and has led 50+ investigations to date. She has worked with regulatory counterparts from Asia, Africa, Europe, and South America. She also maintains close contact with other US Federal agencies. Prior to joining FDA, she worked for the private sector in the biotechnology industry.
Lakecha has a Bachelor of Science in General Biology from the School of Natural and Social Sciences at California State University, Los Angeles. She is a Long Beach resident and works from the Long Beach World Trade Center. In her free time, she enjoys being with family, exploring local areas, and cooking.
Lakecha can be reached via email at: LakechaNLewisNTEU212@gmail.com.