Accredited Third-Party Certification Program

The FDA named ANSI-ASQ National Accreditation Board as the first recognized accreditation body under the Accredited Third-Party Certification Program. Accredited Third-Party Certification is a voluntary program in which FDA recognizes “accreditation bodies” that will have the responsibility of accrediting third-party “certification bodies.” The certification bodies will conduct food safety audits and issue certifications of foreign food facilities.

These certifications will help eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food.
The Agency’s imported food goal is to address potential safety issues before the food reaches the United States and ensure that imported foods are produced in accordance with the same safety standards as those required of U.S. foods.

For more information, visit the FDA’s site.

FDA Foreign Food Facility Inspection

FDA Draft Guidance released December 2017– FDA Foreign Food Facility Inspection

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance which updates the FDA’s interpretation of “refusal of inspection.” Previously, the FDA requires food facilities receiving notice of FDA inspection to confirm acceptance of the inspection within 5 business days, but has now stated that the FDA expects a confirmation within 24 hours. Failure to confirm within 24 hours may be considered refusal of inspection, resulting in delays of the food facility’s future food shipments to the United States. Also, any attempts to limit or condition the inspection in any way may be deemed a refusal of inspection, resulting in similar disruptions to the facilities shipments to the US.

What are the Consequences of Being Deemed a Refusal?

Facilities that refuse inspection are placed under Import Alert 99-32. Consequently, their food shipments face refusal of admission at the port of U.S. entry. Additionally, the food facility’s FDA registration may be suspended.

How Can I Prevent Being Deemed a Refusal?

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Food Safety Modernization Act

FDA Guidance and Training Programs

In December, CFSAN published a number of documents related to its ongoing FDA Food Safety Modernization Act (FSMA) implementation process. On December 14, 2016, CFSAN published a final rule establishing user fees for its voluntary third-party certification program for food safety audits of foreign food facilities.

On December 6, 2016, CFSAN issued a final guidance setting forth model standards to be used by recognized accreditation bodies to qualify third-party certification bodies. Both documents are important steps in FDA’s rollout of the third-party certification program.

In addition, on December 21, 2016, CFSAN published an updated training strategy for FSMA, which includes grants to facilitate training and encompasses public-private alliances that provide education on FSMA requirements. In late December, FDA also issued a revised draft Q&A guidance regarding food facility registration. CFSAN describes its FSMA strategy as “evolving” and we can expect additional updates as remaining FSMA rules are fully implemented.

Adverse Event Report Data for Foods and Cosmetics

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Urgent FDA Food Facility Registration Service

All foreign food facilities are required to register with the U.S. FDA. If your food facility registration was not renewed in 2018, Register-FDA offers an expedited service to ensure your shipments are not delayed.

REGISTER-FDA U.S. AGENT & REGISTRATION SERVICE INCLUDES:

  • Preparation, submittal, and renewal of your FDA Food Facility Registration
  • Electronic Certificate of Registration
  • U.S. Agent Services

FDA CONTACT: Register-FDA serves as the communication link between FDA and your foreign facility, so that FDA can contact us for routine matters and when an emergency occurs. This means that we are accessible to FDA 24 hours a day, 7 days a week.
INSPECTION NOTIFICATION: Register-FDA will assist you when you are notified of an FDA inspection and help with communication between your company and the FDA.
CUSTOMS CLEARANCE: Register-FDA Corp will communicate with your customs broker and freight forwarder on your behalf to provide information about your FDA registration.
REGISTRATION UPDATES: Any changes to the data on your registration must be submitted to FDA within 60 days. Register-FDA updates your registration at no cost.
PRIOR NOTICE: A Prior Notice submission must be filed with FDA prior to each shipment of food to the United States. Register-FDA can instruct your customs broker on the Prior Notice filing requirements.

Register-FDA provides professional guidance so your facility complies with U.S. Food and Drug Administration (FDA) rules. We offer fast, high-quality service at the most competitive rate.

 

See for the current number of foreign registered facilities by country, the table below.

 

Foreign Countries with ≥ 900 Registered FacilitiesNO. Registered Foreign Facilities (212,183 TOTAL)
TOTAL ( 24 countries)99,889 (47% of all foreign)
JAPAN14092
FRANCE10577
ITALY10383
CHINA9918
MEXICO9842
CANADA6871
SPAIN4803
KOREA, REPUBLIC OF4007
INDIA3558
GERMANY2408
CHILE2304
BRAZIL1972
UNITED KINGDOM1935
TAIWAN1778
ARGENTINA1598
COLOMBIA1537
VIET NAM1536
THAILAND1530
PERU1513
RUSSIAN FEDERATION1428
AUSTRALIA1392
ECUADOR1361
NEW ZEALAND1228
GREECE1208
TURKEY1110

Food Safety Modernization Act

U.S. FDA Rules Impacting Food Exporters

by register-FDA

THIS UPDATE IS FOR INFORMATION PURPOSES ONLY – IT IS NOT INTENDED TO PROVIDE ADVICE

Every year, about 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases in the United States. This is a significant public health burden that is largely preventable and are addressed in the FDA Food Safety Modernization Act (FSMA).

Several of the new rules to implement FSMA will have an impact on food exporters. We will discuss the main changes and how they will impact the food supply chain from farm to exporters and importers in more detail below. Continue reading