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  1. Inspections to Protect the Food Supply

Foreign Food Facility Inspection Program Questions & Answers

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Selecting Foreign Food Facilities for Inspection

A: The U.S. Food and Drug Administration (FDA) has increased the number of routine inspections of all food facilities to meet new requirements mandated by the FDA Food Safety Modernization Act (FSMA), which was signed into law by the President on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

Under FSMA, FDA will continue its practice of selecting facilities for inspection based on risk. FSMA required FDA to immediately increase inspections of both foreign and domestic food facilities, including manufacturers/processors, packers, repackers, and holders of foods under FDA jurisdiction, and mandated an inspection frequency, based on risk, for food facilities. All high-risk domestic facilities must be inspected within five years of enactment and at least once every three years after that. Within one year of enactment, the law directed FDA to inspect at least 600 foreign facilities and to double those inspections every year for the next five years.

FDA’s foreign surveillance inspections are designed to identify potential food safety problems before products arrive in the United States, to determine the compliance status of facilities with FDA’s requirements and food safety standards, to help the agency make admissibility decisions when food products are offered for importation into the United States, and to help ensure that food products under FDA’s jurisdiction meet U.S. requirements under the Federal Food, Drug, and Cosmetic Act.

These routine inspections are not conducted as part of a public health emergency, but are an important way for FDA to ensure that foreign food facilities exporting to the U.S., and their products, meet U.S. requirements. It is important to note that routine inspections are designed to evaluate a facility’s adherence to applicable U.S. laws and are not designed to assess a Competent Authority’s food safety system. As such, these inspections are different from systems audits.

For additional information please visit FDA Food Safety Modernization Act. For information on the increase of inspection please visit: Inspection and Compliance and Targeting of Inspection resources for Domestic Facilities (Please see Section 201 (D)).

A: FDA’s selection of foreign food facilities for inspection is based on an overall, cross-cutting risk profile. The primary factors contributing to a facility’s risk profile include the following: (1) the food safety risk associated with the commodity (the type of food), (2) the manufacturing process, and (3) the compliance history of the facility, such as refusal rates for products that were denied entry into the United States. In addition, section 201 of FSMA requires FDA to identify high-risk facilities and allocate resources to inspect facilities according to the known safety risks, and includes several other factors to consider when developing a facility’s risk profile.

As stated above, the food safety risk associated with the commodity is a primary factor contributing to a facility’s risk profile. High risk food commodities include, but are not limited to, modified atmosphere packaged products; acidified and low acid canned foods; seafood; custard filled bakery products; dairy products including soft, semi-soft, soft ripened cheese and cheese products; unpasteurized juices; sprouts ready-to-eat; fresh fruits and vegetables and processed fruits and vegetables; spices; shell eggs; sandwiches; prepared salads; infant formula; and medical foods. This list is not exhaustive. FDA may conduct routine inspections of other food commodities as part of its surveillance activities.

Please visit the FSMA Domestic Facility website for information on how FDA currently identifies a high risk food facility in the domestic arena. FDA is working on a similar risk categorization scheme, as developed for the selection of domestic facilities, to further describe the selection of foreign food facilities for inspection. It will be added to this website when completed.

A: The purpose of an FDA inspection is to determine a facility’s compliance with the Federal Food, Drug, and Cosmetic Act and relevant regulations of Title 21 of the U.S. Code of Federal Regulations (CFR), including, when applicable, Part 110 (Current Good Manufacturing Practices (GMP) in Manufacturing, Packing, or Holding Human Food) and any other U.S. regulations applicable to the specific type of food produced. For instance, canned foods will be inspected for compliance with the low-acid canned or acidified food regulations in 21 CFR Parts 113 and 114. Dietary supplements will be inspected for compliance with good manufacturing practices for dietary supplements, 21 CFR Part 111. A single inspection may focus on multiple requirements, such as a canned tuna product that may be inspected for compliance with seafood hazard analysis and critical control point (HACCP) systems, canning regulations, labeling requirements and current GMPs.

Please note that these are routine inspections of individual facilities designed to evaluate a facility’s adherence with applicable U.S. laws and are NOT system audit visits designed to evaluate a country’s Competent Authority food safety system.

Communications with Foreign Embassies and Competent Authorities

Before an Inspection- Communications with the Food Facility

Refusal to Permit Inspection

During an Inspection

After an Inspection

Food Facility Biennial Registration Renewal

Re-inspection Fees

Publicly Available Inspection Results

Additional Information

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