Attorney Tracey Topper Gonzalez helps clients engaged in manufacturing, importing, marketing, and distributing cosmetics, OTC drugs, dietary supplements, medical devices, and other FDA-regulated consumer products navigate strict regulatory requirements, anticipate and manage risk, and defend against challenges.
Tracey reviews packaging, labeling, ingredient lists, nutrition facts, marketing/advertising materials, user manuals, websites, and other materials for FDA and FTC compliance. She also assists clients with claim substantiation, 766 reconditioning requests, FDA detentions/refusals, establishment inspections, and other compliance issues. Clients also rely on Tracey to handle FDA registrations and listings and 510(k) premarket notifications, advise on FDA litigation, review and implement CGMPs, draft FDA compliance modules, and ensure compliance with CPSC, EPA, and other federal agency regulations.
