Sr. Regulatory Consultant, Quality Solutions and Support, LLC and Former FDA Consumer Safety Officer
Leo J. Lagrotte is a Senior Regulatory Consultant for Quality Solutions & Support, LLC, a consulting practice offering auditing, training and advising to small, medium and large Medical Device and Radiation Emitting Device manufacturers as a follow-up to 20 plus years’ experience with the FDA and USDA. Mr. Lagrotte’s previous regulatory service was preceded by military service as a commissioned Officer in the US Army, and twenty plus years as a civilian owner/operator of retail food establishments including bakeries, restaurants and catering.
His experience with the FDA commenced as an investigator in Florida District/Tampa Resident Post in 2001 conducting inspections of predominately food processing establishments including all HACCP programs, LACF and Acidified Foods then advancing to Medical Devices in 2003 with the Level II Certified Medical Device Investigator (one of forty-four nationally) in 2005 and Southeast Regional Electro-Optics Specialist for Lasers and UV devices both with medical and industrial application in 2004. He also served on the Medical Device Inspection Cadre and conducted over thirty-five foreign inspections of Medical Device, Laser, and X-Ray manufacturers. During the course of his duties with FDA, Mr. Lagrotte conducted over 500 Establishment Inspections domestically.
Presently, Mr. Lagrotte’s focus is to assist the medical device and rad health community in meeting or exceeding compliance with all FDA regulations and Notified Bodies requirements for certifications, completing 510(k) and PMA submissions and responding to regulating officials as necessary on behalf of clients. At FDA and USDA he received a numerous national awards / recognition certificates for exemplary performance. In 2007, he was nominated by Florida District for the Patrick Pouzar Investigator of the Year Award for exceptional performance, integrity and reliability and the FDA Outstanding Service Award in 2011.
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