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FDA-registered facilities must renew their registrations by December 31, 2022

About Us

Jen Diaz

Jennifer Diaz

Jennifer Diaz is a board certificated international attorney, author, public speaker, and is ranked on Chambers and Partners. She is considered a leading expert in International Trade Law by The Florida Bar. Established in 2016, the woman-led, multi-lingual consulting firm specializes in FDA compliance and U.S. agent services. 

Mrs. Diaz is an expert in working with the many Federal agencies that regulate trade, Including the U.S. Food & Drug Administration (FDA).

She is passionate about assisting clients with successfully navigating CBP and FDA detentions. She has vast experience in assisting with responding to CBP Requests for Information (CBP Form 28), responding to Notices of Action (CBP Form 29), and submitting Protests to CBP. Mrs. Diaz frequently assists companies in applying for and being accepted into the Customs-Trade Partnership Against Terrorism (CTPAT) program, assisting with validations, as well as yearly updates and ongoing training. She ensures companies are in compliance with FDA by reviewing product labeling, assisting with registration and any necessary pre-market approval requirements for food, cosmetic, over the counter drug, dietary supplements, alcohol, tobacco and medical devices. She specializes in assisting in mitigating the impact of enforcement actions by federal government agencies. She successfully handles FDA detentions, refusals, voluntary recalls, removal from FDA’s import alert list, and responses to warning letters and FDA 483 inspection observations. 

Diaz has been a champion of global organizations within her industry internationally as well as locally in South Florida. Since 2006 her she has been committed to the Organization of Women in International Trade (OWIT), a worldwide nonprofit organization that focuses fostering international trade and the advancement of women in business. Diaz served as both the South Florida President (2010-2011) and as the international President (2019-2020), overseeing over 20 chapters, with 3,000 members in eight countries across the globe, and leading capacity building workshops and conferences in Nairobi, Kenya and Tampa, Florida. 

In 2020, she was named as a Chambers ranked top attorney for International Trade Law. Considered to be the most prestigious, independent legal industry referral guide, the Chambers USA guide ranks the top lawyers and law firms across the United States of America based on legal merit and yearly evaluations. Diaz regularly provides customized training and comprehensive programs on import and export compliance for small to mid-size enterprises and Fortune 500 companies globally.

Diaz received her Juris Doctor from Nova Southeastern University and Bachelors of Science from the University of Miami. She was a cohort participant in the Goldman Sachs 10,000 Small Business Program at Miami-Dade College, an internally-recognized top accelerator to advance small businesses and entrepreneurship globally. She resides in Miami, Florida, with her two children (one, a fur child) and husband.

Compliance Successes:

  • Assist clients in major voluntary product recalls with the FDA.
  • Assist clients in being successfully removed from FDA Import Alerts.
  • Routinely assist importers in obtaining the expedited release of time sensitive merchandise detained by FDA.
  • Successfully assist in mitigating liquidated damages claims from FDA for failure to export or destroy refused merchandise under FDA and CBP regulations.
 

Press:

 

Articles and Publications

  • Co-Author, Changes In Gluten-Free Labeling: A Closer Look at TTB and FDA Regulations, Food and Drug Law Institute Update Magazine, Publication January/February 2013.

Presentations

  • Webinar, Reedtech, “How Import Compliance Ties into FDA Compliance: Your Checklist to Prepare for 2021,” December 9, 2020.
  • Webinar, FDANews, Top CBP and FDA Enforcement Issues for Imports of FDA Regulated Products, February 25, 2020.
  • Webinar, AudioEducator CLE, “U.S. FDA Requirements for Imported Food” April 25, 2018.
  • Webinar, U.S. FDA Requirements for Imported Cosmetics, Audio Educator, January 31, 2018.
  • Miami, FL, Miami Free Zone, FDA FSMA Compliance Seminar for Importers, Diaz Trade Law Firm, May 18, 2017.
  • Webinar, “Mitigating FDA, Customs Enforcement Actions for Imported Goods Best Practices for Importing Medical Products, Foods & Cosmetics,” FDANews, May 10, 2016.
  • Miami Beach, Florida, “How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices and Streamline the Import Process” FIME International Medical Expo – Miami Beach Convention Center, August 5, 2015.
  • Miami, Florida, “FDA Documents,” Florida Customs Brokers and Forwarders Association (FCBF) Legal Seminar Series, February 20, 2013.
  • Miami Beach, Florida, FIME, “How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and CBP Issues for Medical Devices,” August 8, 2012.
  • Miami Beach, Florida, IFE Americas 10th Americas Food and Beverage Show, FDA & You: Food Importing seminar Regulations (Focus: Organics), October 29, 2007.
  • Orlando, Florida, FDA AND YOUR FOOD SAFETY, Best Practices for Importing Food, Dietary Supplements, and Medical Devices, Florida Customs Brokers and Forwarders Association (FCBF), September 11, 2007.
  • Fort Lauderdale, Florida, FDA AND YOUR FOOD SAFETY, Best Practices for Importing Food, Dietary Supplements, and Medical Devices, Florida Customs Brokers and Forwarders Association (FCBF), August 22, 2007.
 

Education

  • Nova Southeastern University, J.D.
  • University of Miami, B.A.
Carlos Ortiz fsvp Inspector

Carlos Ortiz

Mr. Ortiz is a veteran FDA professional with over 20 years of Agency experience and also a veteran of the US Air Force and Army. While in FDA, he served as Regional Activities Manager of the FDA’s Division of Import Operations for approximately ten years. In that role, he was responsible for reporting on the FDA’s import operations program and provided import guidance to the regulated industry, other stakeholders, and the field investigators in the Southeast Imports Division. He also served as a member of the Foreign Food Cadre and performed various GMP and HACCP inspections in Japan, China, Mexico, Germany, Ecuador, and India. Mr. Ortiz began his FDA career in 2002 as a field investigator in the Atlanta District specializing in imports and food inspections while keeping updated on regulations, policies, and guidelines on Food Safety Modernization Act (FSMA), Foreign Supplier Verification Program (FSVP), Voluntary Qualified Importer Program (VQIP), and Preventive Controls Qualified Individual (PCQI). In 2008 he transferred to the Center for Food Safety and Applied Nutrition as Compliance Officer focusing on dietary supplement and nutrition label reviews.

Activities and Memberships

  • Regulatory Affairs Professional Society
 

Education

  • Biology, BS
  • Business Administration, BS
  • Currently working on a Master of Business Administration
Ariana Malpica

Ariana Malpica

Ariana received a bachelor’s degree in Mathematics from University of Carabobo in Venezuela. She speaks both Spanish and English fluently. She has worked in the customer service and business administration fields since 2012. Ariana has a terrific capability to work under pressure, has an excellent ability to work with numbers, and has a good eye for detail; all qualities she has developed thanks to her math college degree. Her knowledge and first-hand experience in customer service industry assist with her capability to understand our client’s needs and provide the required support to our attorneys. 

Since 2018, Ariana has assisted foreign and domestic food facilities in registering with the FDA. Ariana ensure registrations are up to date; and guides facilities with the process of obtaining a DUNS (Dun & Bradstreet) number to comply with the FDA Food Facility Registration (FFR) Unique Facility Identifier (UFI) requirements.

Apply to become an independent consultant with Diaz Trade Consulting today.

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