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Overview of FDA Food


December 10, 2014

David Kelly, M.A., M.I.M., International Affairs Program Manager

Office of Regulatory Affairs
Office of Global Regulatory Operations and Policy
U.S. Food and Drug Administration
• Overview of FDA and the Office of
Regulatory Affairs

• Overview of ORA food inspections

• Current issues in FDA food regulation

FDA Organization
Office of the National
Commissioner Center for

Office of Office of
Food Global
and Vet Office of Medical Operations
Med Products

Office of Office of
Center for Center for Regulatory International
Food Veterinary Affairs Programs
Safety & Medicine Center for Center for Center for Center for
Applied Drug Devices & Biologics Tobacco
Nutrition Evaluation & Radiological Evaluation & Products
Research Health Research
Office of Regulatory Affairs
• District Staff
– 1,810 Consumer Safety Officers in the field
• HQ Inspection Staff
– Dedicated Foreign Food Cadre
– National Experts
• Office of International Programs – FDA
offices overseas
Office of International
• Operational investigators
– India
– China
– Latin America
• Work assigned and reviewed by ORA HQ

FDA Food Inspections
Types of Inspections:
– Surveillance and For Cause
– Assignments from Centers, e.g.,
avocadoes, nut butter
– Emergencies
– Adverse Events
– Complaints
FDA Food Inspections, cont’d
CFSAN – 24 compliance programs including:
– fresh produce, acidified and low-acid canned food,
seafood, dietary supplements, infant formula, color
additives, imported food, etc.
CVM - 12 compliance programs including:
– feed contaminants, feed manufacturing, etc.
FDA Food Inspections, cont’d
Annual Work Plan for Inspections

Designed to provide the field offices with foreign

and domestic resources and output projections
deemed necessary to carry out FDA’s mission
during the fiscal year (October 1st – September
FDA Food Inspections, cont’d
• Investigators Operations Manual, Chapter 8 –
• Investigation overview:
– notification of manufacturer and competent authority
– show credentials
– opening meeting with management
– tour of the facility
– physical and environmental sampling
FDA Food Inspections, cont’d
– closing meeting with management
• may issue 483
• will issue inspection report
• finding will be: 1) official action indicated (OAI); 2) voluntary
action indicated (VAI); or, 3) no action indicated (NAI)
FDA Food Inspections, cont’d
When Deficiencies Are Found (Non-
– Evidence documentation collected
– Discussed with firm management
– Seek promise from firm to take corrective
– Warning provided to firm management if
violations are not corrected
FDA Food Inspections, cont’d
• Official FDA action may be taken, including:
– Advisory Actions
– Warning Letters
– Untitled Letters
– Product Recall
– Import Alert
• Judicial Actions may be taken, including seizure,
temporary restraining order, injunction
Top 10 FY14 Imports
from Sri Lanka
Product Type Value
1. Fishery/Seafood Products $44,294,252
2. Coffee/Tea $22,931,550
3. Spices, Flavors and Salts $22,290,297
4. Nuts/Edible Seeds $8,415,160
5. Miscellaneous Food-Related Items $5,723,485
6. Vegetable Oils $4,654,864
7. Soft Drinks/Water $3,575,932
8. Fruit/Fruit Products $2,821,925
9. Cosmetics $1,803,549
10. Beverage Bases/Concentrates/Nectar $1,109,718

The values listed above are declared values by the importers or entry filers and may not
be entirely accurate.
• Globalization

• Complexities in Manufacturing Technologies

• Complexities in Products & Product Combinations

• Emergent Public Health Hazards

• Resources required to keep pace with growth of industry

• Consumer demands/dependencies (i.e., fresh fruits all year

David P. Kelly
ORA International Affairs Program
E-mail: DavidP.Kelly@fda.hhs.gov