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Many U.S. importers are required to comply with the U.S. Food and Drug Administration (FDA) Foreign Supplier Verification Program (FSVP) rule by May 30, 2017.

Finalized in November 2015 under the Food Safety Modernization Act (FSMA), FDA’s FSVP rule requires “FSVP Importers” to perform certain activities to verify that the food they import is produced in a manner that meets U.S. safety standards. If you are unsure whether you are considered an FSVP Importer, Registrar Corp’s free FSMA Wizard can assist you in determining your potential requirements.

Evaluating and Approving Suppliers

FDA’s FSVP rule requires that FSVP Importers import only from approved foreign suppliers, although they may import from an unapproved supplier on a temporary basis.  To approve a supplier, an FSVP Importer must consider the supplier’s compliance with FDA food safety regulations, including whether the supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety.

Comments in the final rule regarding this requirement reflect industry concern that FDA’s website and compliance databases can be hard to navigate.  To evaluate a supplier’s compliance using FDA’s website, an FSVP Importer has to search each of FDA’s applicable databases for each individual supplier.  Registrar Corp’s FDA Compliance Monitor allows users to easily evaluate food facilities’ FDA compliance statuses.  The Monitor compiles data on FDA Import Alerts, Warning Letters, Import Refusals, and Inspection Classifications for a user’s suppliers in a simple dashboard, which also tracks whether suppliers are approved.

Risk-Based FSVPs

FSVPs must be created by a “Qualified Individual,” defined as an individual with the education, training, or experience necessary to perform their assigned activities and the ability to read and understand the language of any records that must be reviewed in performing an activity. An FSVP must include a hazard analysis and appropriate supplier verification activities to provide assurance that these hazards will be significantly minimized or prevented.  Examples of supplier verification activities include audits, records review, and sampling and testing.

What qualify as “appropriate” verification activities for a particular supplier depends on the types of foods being imported and the supplier’s compliance history.  Registrar Corp’s Food Safety Specialists act as Qualified Individuals and can develop or review FSVPs to ensure they are appropriate for your specific needs.

Corrective Actions

Should an FSVP Importer become aware of non-compliance by one of its approved suppliers, the importer must ensure corrective action is taken.  Registrar Corp can assist in implementing corrective actions. For example, action taken to have a foreign supplier removed from import alert may be considered an appropriate corrective action.  Registrar Corp can help facilities create and submit a petition to FDA for removal from import alert.  Additionally, labeling errors are one of the largest causes for warning letters and detentions.  Registrar Corp can review food labeling and ingredients for FDA compliance.

For more information, attend Registrar Corp’s free FSVP webinar or utilize their 24-hour online Live Help.

This article was originally published as a press release.

         

FDA Food Reg Stats 2017

There were 149,933 food facilities registered with the U.S. Food and Drug Administration (FDA) as of February 2, 2017.  Of those registered facilities, 70,976 (47%) were outside of the United States. See the number of registrations by country here.

The ten countries with the largest number of FDA registered food facilities remain the same in 2017 as those reported in 2016:

United States (78957)
Japan (9211)
France (7336)
Italy (6169)
China (5236)
Mexico (4499)
Canada (4169)
Spain (3208)
Republic of Korea (2393)
India (1944)

Earlier research revealed there were 207,653 food facilities registered with FDA on January 1, 2016, meaning there was a 28% decrease in the number of registered facilities between then and February 2017.  This steep drop in registered facilities is likely due to FDA removing food facility registrations that were not properly renewed by December 31, 2016 from its registration database

This drop in registered facilities is greater than the 14% drop that occurred after the 2014 renewal period.  This is likely due to new verification requirements implemented during the 2016 renewal period.  Food facilities located outside of the United States are required to designate a U.S. Agent for FDA Communications in their registration renewal.  Unlike in previous years, individuals or entities listed as U.S. Agents in 2016 were required to confirm with FDA acceptance of their designation and corresponding responsibility.  FDA did not consider a facility’s 2016 renewal confirmed unless the designated U.S. Agent affirmatively agreed in writing. If a foreign facility submitted its registration renewal but its U.S. Agent did not affirmatively agree, its registration was removed from FDA’s food facility registration database.

Manufacturing, processing, packing, or storing food for US consumption without a valid FDA registration is a prohibited act.  Many facilities do not realize that FDA removed their registrations until problems occur.  To avoid costly detentions or regulatory action, it’s prudent for all food facilities to verify that their FDA registrations were properly renewed for 2017 before continuing with business as usual.  This is especially true for food facilities located outside the U.S.  Registrar Corp will verify that your FDA food facility registration was properly renewed at no cost.  Facilities that need a U.S. Agent may retain Registrar Corp.  Simply contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

This article was originally published as a press release

         

The U.S. Food and Drug Administration (FDA) recently removed from its database of active registrations all medical device establishments that did not register for 2017.  Owners or operators of device establishments must register annually with FDA.  In early February, the Agency warned industry that it would remove all establishments that had not registered for 2017 by February 23.

Devices manufactured, prepared, propagated, compounded, or processed in an unregistered establishment are misbranded and thus subject to regulatory action if sold in the United States.  Registrar Corp is urging medical device companies to confirm their establishments are listed in FDA’s database as registered for 2017 before continuing business as usual: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

The registration fee for fiscal year (FY) 2017 is $3,382.  Registrar Corp can help medical device establishments verify that their registrations were completed for 2017 as well as register device establishments with FDA and facilitate payment of the associated fees.  For assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

         

On February 14, Registrar Corp, a U.S. Food and Drug Administration (FDA) consulting firm, launched two free tools to assist food facilities in complying with FDA requirements for Low-Acid Canned and Acidified Foods.

Most facilities that manufacture, process, pack, or store food intended for consumption in the United States are required to register with U.S. FDA as food facilities. Food facilities that produce certain shelf-stable, hermetically-sealed low-acid canned or acidified foods must also obtain a Food Canning Establishment (FCE) registration.  FDA requires FCE manufacturers to file documentation for each process used in the production of Low-Acid Canned and Acidified Foods and assigns unique “Submission Identifiers” (SIDs) to each of these “Process Filings.” Common examples of foods subject to FDA’s FCE and SID requirements include canned tuna, canned roasted red peppers, and coconut water.

Registrar Corp’s FCE Wizard allows users to identify whether their products are subject to these FDA FCE and SID regulations. Users simply answer a few questions, and the FCE Wizard generates a free report indicating possible requirements for each of the facility’s products based on factors such as pH, water activity, and ingredients.

For individuals aware that their products are subject to FCE-SID requirements but uncertain if a particular SID remains valid, Registrar Corp has developed the SID Verifier.  Registrar Corp’s SID Verifier allows users to verify whether SIDs are currently on file in FDA’s database.  Manufacturers, importers, and customs brokers filing entries of Low-Acid Canned and Acidified Foods will find this tool especially helpful, as valid SIDs must be submitted as “Affirmation of Compliance Codes” (AofC) when importing these products into the United States.  Verifying SIDs before filing can help avoid time-consuming detentions and entry errors that may lead to low filer evaluations.

Registrar Corp’s team of FCE specialists provides assistance with the FCE registration process and offers guidance as to required elements, formats, and particularities of SID submissions.  For further assistance with FDA FCE and SID requirements, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

To use Registrar Corp’s FCE Wizard, click here.
To use Registrar Corp’s SID Verifier, click here.

This blog was originally published as a press release.

         

On February 7, the U.S. Food and Drug Administration (FDA) e-mailed medical device establishments that did not complete their annual registration for 2017.  According to the e-mail, establishments that do not register and pay the associated fees by February 23, 2017 will have their registrations removed from FDA’s database of active registrations. Medical devices manufactured, prepared, propagated, compounded, or processed in an unregistered establishment are misbranded and thus subject to regulatory action if sold in the United States.

FDA Email Unregistered Device Establishments

The registration fee for fiscal year (FY) 2017 is $3,382.  Registrar Corp can help medical device establishments verify that their registrations were completed for 2017 as well as register device establishments with FDA and facilitate payment of the associated fees.  For assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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