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

Objectives 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 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

Office of Regulatory Affairs

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

Office of International Programs 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. http://www.fda.gov/food/complianceenforcement/foodcomplianceprograms/ucm071496.htm CVM - 12 compliance programs including: feed contaminants, feed manufacturing, etc. http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/ucm112583.htm

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)

FDA Food Inspections, cont’d Investigators Operations Manual, Chapter 8 – Investigations (http://www.fda.gov/iceci/inspections/iom/default.htm) 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-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

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.

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

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