1. Overview of FDA Food Inspections
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

2. Objectives Overview of FDA and the Office of Regulatory Affairs
Overview of ORA food inspections
Current issues in FDA food regulation

3. FDA Organization Office of the Commissioner Office of Food and Vet Med
National
Center for
Toxicological
Research
Office of Food and Vet Med
Office of Global Operations
Office of Medical Products
Discuss the 6 product centers, NCTR and ORA as making up 8 centers. Slide has been updated to reflect directorate structure. Explain grouping of centers under the directorates.
Office of Regulatory Affairs
Office of International Programs
Center for
Food
Safety &
Applied
Nutrition
Center for
Veterinary
Medicine
Center for
Drug
Evaluation &
Research
Center for
Devices &
Radiological
Health
Center for
Biologics
Evaluation &
Research
Center for Tobacco Products

5. Office of Regulatory Affairs

6. Investigators District Staff HQ Inspection 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

7. Office of International Programs
Operational investigators
India
China
Latin America
Work assigned and reviewed by ORA HQ

8. FDA Food Inspections Types of Inspections: Surveillance and For Cause
Assignments from Centers, e.g., avocadoes, nut butter
Emergencies
Adverse Events
Complaints

9. 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.

10. 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 30th)

11. FDA Food Inspections, cont’d
Investigators Operations Manual, Chapter 8 – Investigations (
Investigation overview:
notification of manufacturer and competent authority
show credentials
opening meeting with management
tour of the facility
physical and environmental sampling

12. 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)

13. FDA Food Inspections, cont’d
When Deficiencies Are Found (Non-Compliance):
Evidence documentation collected
Discussed with firm management
Seek promise from firm to take corrective action
Warning provided to firm management if violations are not corrected

14. 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

15. 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.

16. Challenges 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 round)
ORA inspects < 1% of imported goods; 300 ports; > 300,000 manufacturing facilities overseas
Consumer demands/dependencies require variety/availability and an expectation that all food will be safe and nutritious regardless of the source
Advances in science have resulted in technologies that are completely automated and/or utilize complex processes
The line between “low risk” vs. “high risk” has become increasingly fuzzier, e.g., peanut butter, pet food, LACF

17. CONTACT: David P. Kelly ORA International Affairs Program Manager