Larry Spears is currently an independent consultant and President of L.Spears Consulting, LLC, where he provides regulatory and compliance advice to medical device and pharmaceutical firms in meeting FDA requirements. He also served for over two years as a Director in Deloitte & Touche LLP's Health Sciences practice. Prior to joining Deloitte, he had 34 years of experience with the Food and Drug Administration (FDA) as an investigator, compliance officer, compliance manager and director. Larry's most recent assignment at FDA was the Deputy Director of the Office of Compliance, Center for Devices and Radiological Health, where he gained considerable experience in inspection outcome assessment, regulatory case management , and recall evaluation and classification. He also has extensive knowledge and experience in the application of FDA law, regulations, compliance and enforcement programs, policy, and strategy.
As an independent consultant and while at Deloitte, Larry has used his FDA insights and experience to assist clients in developing quality and risk strategies through the performance of activities such as: remediation of FDA Warning Letters and FDA 483s, mock inspections, process validation and contract manufacturing support, PMA inspection preparation, adverse event reporting direction, and overall regulatory governance.