Gus Suarez, P.A. - The Health+Business Law Group

Ann Marie Gaitan, Esq., Of Counsel

Location: Charlotte, NC

Phone: 866-576-1279


Mrs. Gaitan’s practice focuses on products regulated by the Food and Drug Administration (FDA), the Department of Agriculture (USDA), the Environmental Protection Agency (EPA) and the Federal Trade Commission (FTC).

Mrs. Gaitan regularly counsels regulated entities on the laws, regulations and policies affecting foods, dietary supplements, medical devices, drugs, cosmetics and combination products. She represents manufacturers, importers, processors, distributors and marketers on compliance and enforcement matters before a wide range of federal regulatory agencies. Mrs. Gaitan’s practice includes representation of clients in regulatory compliance issues relating to labeling, packaging, claims, ingredients, record keeping, good manufacturing practices and marketing. She also provides counsel to clients preparing for an FDA inspection as well as responding to inspectional findings (483) and warning letters. 

Mrs. Gaitan has successfully removed numerous clients from FDA Import Alert, and worked with clients to develop and implement effective Corrective Action Plans (CAP) and revised Hazard Analysis and Critical Control Points (HACCP) plans. 

In addition, Mrs. Gaitan has extensive experience in the review of websites, advertising and marketing materials, as well as the representation of companies before the FTC.  She has successfully negotiated consent decrees with the FTC, while also counseling clients on standards for truthful and non-deceptive advertising, evidentiary support for claims, use of testimonials, comparative advertising, disclosure adequacy, as well as other common advertising practices regulated by the FTC.

Bar Admissions

  • Florida, 2006

Education

  • St John's University, School of Law
    • J.D. - 2005
  • George Washington University, Washington, District of Columbia
    • B.A. - 2000

Classes/Seminars

  • Presenter, "Medical Device Excise Tax & Establishment Registration Update: New Requirements for 2013", Sandler, Travis & Rosenberg, P.A., Webinar, January 10, 2013 - Present
  • Presenter, "FSMA IMPLEMENTATION: What to Expect from FDA in 2013" , Sandler, Travis & Rosenberg, P.A., Webinar, January 8, 2013 - Present
  • Presenter, "LA NUEVA LEY DE ALIMENTOS "FSMA: Obligación de Reinscribir Su Planta con FDA en 2012 Para Evitar Detención o Confiscación", FDA Solutions Group, LLC, Webinar, October 18, 2012 - Present
  • Presenter, "FSMA IMPLEMENTATION: Protect Your Supply Chain: What You Need to Know About FSMA's Food Facility Registration", FDA Solutions Group, LLC, Webinar, September 20, 2012 - Present
  • Guest Speaker, Legal Update on FDA FSMA and MDUFA issues, Florida Customs Brokers and Forwarder (FCBF), October 17, 2012 - Present
  • Presenter, "How FDA's New Food Safety Modernization Act (FSMA) will change the way importers and brokers do business", XIII Business Alliance Expo – Trade Colombia, August 1, 2012 - Present

 

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