Transcript presentation

FDA International
Food Investigator
LCDR Jane C. Chen, RD, BS, MBA, DHSc.
US PHS Conference
June 21st, 2011
Overview
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FDA International Programs
Dedicated Food Cadre
Questions
FDA International Program
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FDA has conducted international inspections
since 1955
Over the years, international inspections
have increased in both complexity and
frequency and cover all food products
subject to regulation by FDA.
FDA is increasing the number of inspections
of foreign food processing facilities
Foreign inspections are
designed to:
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Identify potential food safety problems before
products arrive in the United States, to determine
compliance status of firms to FDA’s
requirements and food safety standards
Help the agency make admissibility decisions
when food products are offered for importation
into the U.S.
Help ensure that food products under FDA’s
jurisdiction meet U.S. requirements under the
Federal Food, Drug, and Cosmetic Act.
FDA focuses its inspections
on high risk establishments
High risk food establishments
are growers / harvesters,
manufacturers / processors,
packers, repackers, and holders
of “high risk foods,” i.e., those
foods that may present hazards
which FDA believes may present
a high potential to cause harm
from their consumption.
High risk food establishments
include, but are not limited to:
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Modified atmosphere packaged products
Acidified and Low Acid Canned Foods
(AF/LACF)
Seafood
Dairy (including soft, semi-soft, soft ripened
cheese and cheese products)
Fresh/ Processed Fruits and Vegetables
Spices
Unpasteurized juices
Sprouts Ready-to-Eat
Prepared Salads
Medical foods and Infant formula
FDA also identified the
following as high risk:
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products whose formulations do not
include an allergenic ingredient but,
because the products are made in a firm
that also makes allergen-containing
foods, may inadvertently contain an
allergen which is not declared on the
label.
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products with common allergenic
substances including: milk, eggs, fish,
crustaceans, tree nuts, peanuts or
soybeans
Criteria Used for Selecting
Facilities for Inspection
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Selection of foreign high risk establishments
is based on a risk evaluation of foods
imported into the United States.
FDA analyzes global and country specific
data regarding high risk products in order to
determine the countries/firms to inspect
which includes:
– The number of import entry lines (importation
volume)
– and other considerations such as refusal rates on
denied entries.
Typical International Trip
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Generally, FDA is in each country for
three-weeks during each visit
FDA plans to inspect six to nine food
facilities during each visit.
Generally, each food facility inspection
should take one to three days to complete.
International Trips (cont.)
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A country might be visited by FDA at different
intervals throughout the fiscal year to complete
all planned inspections
Starting in fiscal year 2010, FDA notifies the
embassy prior to contacting the competent
authorities and the firms and provides the
embassy with some basic information regarding
the FDA Foreign Inspection process.
FDA will ask the competent authorities for
assistance in order to coordinate the inspections.
International Trips (cont.)
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FDA contacts the firm again by
letter with specific information
regarding:
– proposed inspection dates,
– logistical information
– availability of interpreter assistance.
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These letters are written in
English and the foreign country’s
official language
Inspectional Focus
FDA focuses on the firm’s adherence to
the Federal Food, Drug, and Cosmetic Act
and relevant regulations of Title 21 of the
U.S. Code of Federal Regulations,
specifically Part 110 (Current Good
Manufacturing Practice in Manufacturing,
Packing, or Holding Human Food) and
any other U.S. regulations applicable to
the specific type of food produced by the
facility selected for inspection.
Inspectional Observations
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FDA investigators and analysts will make every
reasonable effort to discuss all observations with
the management of the establishment:
– As they are observed during the course of the
inspection, and/or
– On a daily basis before leaving the facility, and;
– During the inspection closeout meeting at the facility.
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FDA investigators will verify the completed
corrective actions. This may also be completed
during the FDA compliance review process
– in communications with the firm,
– during examinations/sampling at the port of entries,
– and/or during a follow up inspection.
Conclusion of Inspection
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When applicable, FDA issues an FDA-483
(Inspectional Observations form) to the
company’s management at the end of the
inspection
When applicable, FDA takes any necessary
enforcement actions.
Once it is evident to FDA that the firm is in
compliance with FDA’s requirements and food
safety standards, a copy of the Establishment
Inspection Report (EIR) is sent to the firm.
Refusal of Inspection may result in
the following Regulatory Options:
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including taking the refusal into account in determining
whether to sample products or
otherwise examine products from the firm when offered
for import into the United States and in determining
whether such products are subject to refusal of admission
into U.S. commerce.
Section 801(a) of the U.S. Food, Drug and Cosmetic Act
authorizes FDA to conduct examinations, samplings,
detentions and refusals, as they may apply, on articles
under FDA jurisdiction offered for importation into the
United States.
Food Modernization Act
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Signed into law on December 22, 2010
Doubles the number of foreign inspections every
year for the next five years
Projected Foreign Facility Inspection Breakdown
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2011: 600 inspections
2012: 1200 inspections
2013: 2400 inspections
2014: 4800 inspections
2015: 9600 inspections
Dedicated Foreign Food
Cadre
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Established in 2009
Consists of 15 members
Solely dedicated to conducting
international food inspections
Stationed throughout the U.S.
Report directly to headquarters
Expected to complete approximately 40
inspections per year
Additional Information
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For more information please contact or visit:
FDA’s Foreign Food Inspection Program website at:
– http://www.fda.gov/Food/InternationalActivities/ucm196386.htm
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Office of International Programs
– (Tel) 301-796-4600
– (Fax) 301-595-5063
– http://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofInternationalProgra
ms/default.htm5
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Importing into the United States
– http://www.fda.gov/Food/InternationalActivities/Imports/default.htm6
– http://www.fda.gov/Food/InternationalActivities/ucm202422.htm7
– http://www.fda.gov/ForIndustry/ImportProgram/default.htm8
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FDA Industry Systems
– https://www.access.fda.gov/9
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FDA – Food’s Section
– http://www.fda.gov/Food/default.htm10
Reference
Information for slides obtained directly
from FDA Foreign Food Inspection
Program
http://www.fda.gov/Food/InternationalActi
vities/ucm196386.htm
Summery
 FDA International
Programs
 Dedicated Food Cadre
 Questions
Questions?