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FDA-registered facilities must renew their registrations by December 31, 2022

Foreign Supplier Verification
Program (FSVP) Services

The U.S. FDA Food Safety Modernization Act (FSMA) provided the FDA greater authority to prevent unsafe food into the U.S. and increased the FDA’s enforcement powers. The FSMA also gave FDA the power to hold imported foods to the same standards as domestic foods and to suspend a food facilities registration for non-compliance.

Foreign Supplier Verification Program (FSVP) Services

One of the many requirements under FSMA is that food importers (or their agents) must develop a Foreign Supplier Verification Program (FSVP) to provide adequate assurances that their foreign suppliers are producing compliant food. Importers covered by the FSVP regulation must put in place foreign supplier verification programs (FSVPs) to verify that their foreign suppliers are producing food using processes and procedures that provide the same level of public health protection as those required under the preventive controls (for human or animal food) or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling (21 CFR 1.502(a)). 

For more information on FDA requirements visit FDA’s website on importing food here:

GENERALLY, FSVP RULES REQUIRES:

1

Conducting a hazard analysis to determine known or reasonably foreseeable hazards with each food that require a control (21 CFR 1.504)

2

Evaluating the foreign supplier’s performance and the risk posed by a food (based on the hazard analysis) (21 CFR 1.505(a))

3

Using that evaluation to approve suppliers and determine appropriate supplier verification activities (21 CFR 1.505(b))

4

Conducting foreign supplier verification and related activities (21 CFR 1.506)

5

Taking corrective actions (if necessary) (21 CFR 1.508)

6

Maintaining records of these FSVP activities (21 CFR 1.510)

A qualified individual must develop your FSVP. This qualified individual must have the education, training, or experience (or combination thereof) necessary to perform the activity, and must be able to read and understand the language of any records reviewed in performing an activity.

A Preventive Controls Qualified Individual (PCQI) is a person that has successfully completed adequate training or is otherwise qualified through job experience to develop and implement a food safety plan. A PCQI manages important aspects of the food safety program and ensures that preventive controls are effective and proper records are maintained. Diaz Trade Consulting has trained PCQI specialists that are qualified to develop, review, and/or implement your FSVP. 

FDA is actively performing FSVP inspections. Many inspections are resulting in warning letters as the importers do not have the required FSVP in place. Diaz Trade Consulting can assist you in preparing for your FDA inspection, working to develop, review, and/or implement an effective FSVP so that you are prepared for your FDA inspection.

If you want to confirm if you are subject to FSVP – take the FDA’s quiz here:

Contact Diaz Trade Consulting today at

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