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Christine Humphrey

Attorneys

Christine M. Humphrey, Esq

Christine M. Humphrey, Esq. has 17 years of Food & Drug Administration (FDA) experience, and working inside of the FDA for 10 years, Ms. Humphrey focuses her legal practice on FDA matters, including domestic and foreign inspections of all FDA-regulated products; import and export processes; criminal, regulatory and administrative actions; risk management and regulatory due diligence.

Ms. Humphrey has extensive experience in handling seafood HACCP matters, including representation of domestic and foreign processors affected by FDA regulatory actions, criminal investigation and import alerts. Many of Ms. Humphrey's clients seek her counsel to prevent, mitigate or respond to FDA regulatory action against their domestic or foreign facilities, including imported products that are the subject of FDA administrative or Customs' civil enforcement (seizure, monetary penalties or claims for liquidated damages) and criminal investigations related to smuggling. Ms. Humphrey has successful criminal prosecution experience with respect to smuggling of illegal products into the US and has served as co-counsel with the Department of Justice. As an attorney representing the private sector, Ms. Humphrey defends people and companies threatened by regulatory and criminal enforcement.

In addition, she has in-depth knowledge, as a former FDA investigator and a compliance officer, of FDA regulation of all foods (including dietary supplements), drugs, cosmetics, medical devices (Quality Systems Regulations), radiological health, biologics, Investigational Review Boards (IRBs) and clinical investigations.

Publications:

Contributing Commentator for "The Silver Sheet" April 2010 News Letter : FDA Issues First Device 'Close-Out' Letter; Experts Weigh In On Details
Aspatore Books, Inside the Minds: Working with Government Agencies in Food and Drug Law, May 2009
US News and World Report; "Food Safety's Dirty Little Secret" , September 10, 2008
TIME Magazine 85th Edition, Women in Leadership-August 25, 2008
GxP Lifeline, Master control Publication (www.mastercontrol.com) "An Analysis of Heparin Accountability and Pre-emption Where are we now? Part I" August, 2008
"An Analysis of Heparin, Accountability and Pre-emption: Where Are We Now? Part II", Heparin and the FDA Globalization Act of 2008. By Christine M. Humphrey, August 2008
Interviewed in The Take Away-Health - On the Trail of The Hot Tomato: Salmonella Outbreak in Tomatoes; June 2008
Quoted in the Perishable Pundit - Imported Food Safety - April 2008
Clinica, World Medical Device and Diagnostics News, page 12, issue No 1297 of March 7 2008. Ms. Humphrey's comments on the Supreme Court ruling in Riegel v. Medtronic.
Quoted in Food Chemical News on Import Alert 16-131 and Laboratory Practices on Food Imports- November 2007
FDA Guidance re DeContam of Transport Vehicles & Storage Facilities Update - October 14, 2005
FDA Guidance re Hurricanes and Decontam October 7, 2005
Food and Drug Law Journal; "FDA Import Alerts Appear To Be Misbranded", Vol. 58, Issue 4, 2003

Speeches/ Training:

Christine Humphrey Esq. will be the special key note speaker at the conference for Regulatory Landscape in 2011: Adult Autologous Stem Cells and the Practice of Medicine
ICMS conference November 11, 2010 at Las Vegas, Nevada.
Special Guest Speaker for Italy Amercia Chamber of Commerce Food & Beverage Webinar May 11, 2010
UM School of Business - Preemption: Recent Case Law Affecting Prescription Drug and Medical Device Safety - June 05, 2009
Florida Customs Brokers & Forwarders Association., Inc. (FCBF) May 27, 2009: Overview of FDA regulatory updates and issues including but not limited to:

    • Import Safety Plan;
    • Problems in Florida Ports of Entry;
    • Prior Notice Updates;
    • Responding to FDA Notices of Action
    • Import Alerts
    • Petition Process Involving both CBP and FDA

Special Guest Speaker for Italy Amercia Chamber of Commerce - Food and Beverage Webinar - Successfully Exporting Foods to the United States - April 29, 2009
Featured Speaker, Boston Seafood Show - Changes in Food Safety for 2009: How Will Your Company be Affected? - March 16, 17, 2009
Christine M. Humphrey, guest speaker in Hong Kong at The 8th Hong Kong Trade Development Council World Expo held on December 10, 2008. The Seminar is entitled "Effective Use of U.S.A. as a Gateway to Central and South America". The Seminar covers important legal aspects involved in international business transactions between China and Latin America utilizing Florida and Miami as a legal and logistics platform
World City Inc. 2008 Perishables "Trade Numbers", a Trade Connections Event held at Sofitel Hotel, Miami, Florida December 17th 2008. Featured Speaker Christine M. Humphrey, Esq.
CBI`s First Premium Forum for the Life Sciences Industry; Anti-Counterfeiting and Anti-Diversion Strategies, October 21, 2008, Vienna, Virginia. "Examine the Regulatory Impact of New Legislation Aimed at Improving Prescription Drug and Medical Device Safety", Christine M. Humphrey, Esq., Former Investigator and Compliance Officer, FDA. October 2008
2008 Americas Food and Beverage Show, "Exporting to the US from Abroad" Seminar presented Sept. 25th Miami Beach Convention Center, Florida
Q1 Productions - International Device Trials Conference - March 2008
Featured Speaker, Boston Seafood Show - February 2008
Food Chemical News - Chicago - October 2007
Mediterranean Experience 2006, Miami , FL - Developing a Successful Strategy for Importing Food into the U.S. Food Litigation, sponsored by American Congress, September 2006
American Conference Institute - Food Regulation and Litigation - Chicago - March 2006
Alimentarius 2006, Barcelona Spain - Importing Food into the U.S.
American Strategic Management Institute (ASMI)- FDA Imports - Supply Chain Security, Los Angeles, April 2004
Generic Pharmaceutical Association (GPhA) - Pharmaceutical Supply Chain - Imports - New York, NY, March 2004
Representing the FDA, Import Enforcement Law Courses 2001-2003
Representing the FDA, World Courier Import Conference 2001
Representing the FDA, BioFlorida Quality Systems Regulation Seminar (Design Control) 2000
Representing the FDA, Orthopedic Surgical Manufacturers Association (OSMA) Design Control Presentation 1999

Professional Memberships:

Florida Customs Brokers & Forwarders Association
ABA International Law Section
Spain U.S. Chamber of Commerce
World City Sponsor - CEO Round Table
BioFlorida Sponsor
Miami Beach Chamber of Commerce
Brazilian American Chamber of Commerce
Italy-America Chamber of Commerce

Awards and Accomplishments:

2011 Top 40 under 40 Lawyers
2010 Top Up & Comer Award, South Florida Legal Guide
Top 50 Entrepreneurs' Award of 2010, South Florida Business Leader
2010 Top Lawyer, South Florida Legal Guide
2009 Mover & Shaker by Business Leader
2009, Top Lawyer, South Florida Legal Guide
The Marquis Who's Who in America 2008
FDA Compliance Officer of the Year, 2003
University of Miami School of Law, cum laude, 2003
University of Miami, Editor in Chief, Business Law Review, 2003
FDA Investigator of the Year, Florida District, 1999
FDA Certification: Traceback of Fresh Produce and Other Commodities, 1999
FDA Certification: Medical Device Level II Expert, 1997
FDA Certification: Seafood HACCP Regulator Training, 1997
FDA Certification: Food and Drug Law Evidence Development, 1995

Areas of Expertise:
Food, Drug & Cosmetic Issues
Custom, Import & Trade Issues
Domestic/Foreign Inspections
Import and Export Processes
Customs & International Trade
Risk Management
Regulation Guidance/Development
Agency Guidance/Development
Bioterrorism
Education:
University of Miami School of Law
Coral Gables, Florida
J.D., cum laude, 2003

Bellarmine College
Louisville, Kentucky
B.A., magna cum laude, 1994
Admitted:
Florida 2004
Areas of Practice:
Custom, Import and Trade Law
Food, Drug and Cosmetic Law