Ann Marie Gaitan, Esq.

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.

Mrs. Gaitan is fluent in Spanish.  She may be reached via e-mail at [email protected] or via telephone at 786.440.8115.

Bar Admissions

• Florida, 2006

Education

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

Presentations, Classes & Seminars:

• Presenter, “Medical Device Single Audit Program (MDSAP): Considerations For Manufacturers”, FIME International Medical Exposition,  August, 2015
• Presenter,“Import for Export: How FDA Regulates Non-Compliant Medical Devices Not Intended for U.S. Consumers” FIME International Medical Exposition,  August 8, 2013
• Presenter, “Importing FDA Regulated Products into the U.S.”, ProChile, Presentation, June 26, 2013
• Presenter, “Medical Device Excise Tax & Establishment Registration Update: New Requirements for 2013”, Sandler, Travis & Rosenberg, P.A., Webinar, January 10, 2013
• Presenter, “FSMA IMPLEMENTATION: What to Expect from FDA in 2013” , Sandler, Travis & Rosenberg, P.A., Webinar, January 8, 2013
• 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
• 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
• Guest Speaker, Legal Update on FDA FSMA and MDUFA issues, Florida Customs Brokers and Forwarder (FCBF), October 17, 2012
• 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

Publications:

•  FL Bar HLS Newsletter, April-May Health Law Updates, Author, “FDA issues Draft Guidance on 3D Printing of Medical Devices”, June 2016.
• FL Bar HLS Newsletter, April-May Health Law Updates, Author, “New FDA Guidance Targets Electronic Health Records in Clinical Trials”, June 2016.
• FL Bar HLS Newsletter, April-May Health Law Updates, Author, “FDA Targets Online Sales of Illegal Prescription Drugs”, June 2016.