Transcript Overview of FDA Food Inspections

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
Center for
Food
Safety &
Applied
Nutrition
Center for
Veterinary
Medicine
National
Center for
Toxicological
Research
Office of
Global
Operations
Office of Medical
Products
Office of
Regulatory
Affairs
Center for
Drug
Evaluation &
Research
Center for
Devices &
Radiological
Health
Center for
Biologics
Evaluation &
Research
Center for
Tobacco
Products
Office of
International
Programs
Office of Regulatory Affairs
Investigators
• 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
Programs
• Operational investigators
– India
– China
– Latin America
• Work assigned and reviewed by ORA HQ
7
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/foodco
mplianceprograms/ucm071496.htm
CVM - 12 compliance programs including:
– feed contaminants, feed manufacturing, etc.
http://www.fda.gov/AnimalVeterinary/GuidanceComplia
nceEnforcement/ComplianceEnforcement/ucm112583.h
tm
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 (NonCompliance):
– 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)
CONTACT:
David P. Kelly
ORA International Affairs Program
Manager
E-mail: [email protected]