What is FSMA VQIP Certification?


FSMA VQIP Certification is a scheme offered by SGS to cover the FDA’s official third-party certification of foreign suppliers. It is an accredited compliance certificate, based on the FSMA Accredited Third-Party Certification (TPP) rule. It helps importers and their suppliers comply with the requirements of the Foreign Supplier Verification Program (FSVP) and VQIP (Voluntary Qualified Importer Program).

About VQIP

The Voluntary Qualified Importer Program (or VQIP) is available to US importers and allows expedited entry of their imported food products into the US. One of the requirements of this expedited entry program is supplier certification under the TPP rule.

One of the advantages of expedited entry under VQIP, is that food entering the US is generally released immediately - the regular process for releasing food at US ports of entry takes between two and seven days. Expedited entry represents a huge advantage for food importers who want to quickly have their products on the retail shelves.

Advantages of FSMA Certification for Foreign Suppliers

Foreign suppliers will greatly benefit from FSMA certification because it reduces the number of requests for proof of FSMA audit and/or other compliance requirements from their US importers. FSMA VQIP certification will also help foreign suppliers to attract more US clients. In addition, foreign suppliers can use their FSMA certification to promote their brands, as they will have a certificate to prove they meet US FDA food safety requirements.

Route to Certification

FSMA VQIP certification can be done in two stages – an optional ‘Consultative Audit’ followed by the ‘Regulatory Audit’.

An optional consultative audit is a full, unannounced audit that will report back to the company any gaps in their system.

A regulatory audit is also a full, unannounced audit. Upon successful completion, SGS will issue an accredited FSMA VQIP certificate.

FSMA VQIP certification is valid for 12 months and a recertification audit is required prior to its expiration.

Route to Certification

Preparing for FSMA Certification

FSMA VQIP certification is issued for the purposes of the FSMA Accredited Third Party Certification Program (TPP) rule. It attests that a facility complies with the applicable food safety requirements of the FD&C Act and FDA regulations. Therefore, a regulatory audit covers all the applicable food safety regulations that FDA has issued for the purposes of food offered for consumption in the United States.

Levels of Compliance

Levels of Compliance

Unlike other voluntary food safety certification schemes, FSMA VQIP certification is a compliance certification. There are 62 regulatory ‘scopes’ for VQIP in FSMA. Those scopes can be categorized as follows:

  • Overarching (or primary) regulations, e.g. Preventative Controls for Human Food, Seafood HACCP, Juice HACCP, etc.
  • General and product-specific regulations, e.g. Food Labeling, Macaroni & Noodles, Bakery Products, etc.

Responsibilities of SGS as Your Certification Body

FSMA VQIP certification entails requirements for certification bodies, such as:

  • Performing facility audits unannounced
  • Ensuring auditors are competent and objective
  • Verifying the effectiveness of corrective actions to address identified deficiencies
  • Complying with the requirements of submitting regulatory audit reports to FDA, providing access and maintaining certain certification documents
  • Notifying FDA upon discovering a condition that could cause or contribute a serious risk to public health

Alternative to FSMA VQIP Certification

For foreign suppliers and importers who are just looking for an FSMA audit certificate but are not interested in VQIP and the expedited entry program, SGS also offers a certification scheme called ‘FSMA FSVP’. Like VQIP, the FSMA FSVP accredited certification program covers the applicable FDA food safety regulations. However, it is a voluntary scheme that addresses the supplier verification requirements in the Preventive Controls rules and the Foreign Supplier Verification Program (FSVP). Therefore, unlike the FSMA VQIP certification scheme, FSMA FSVP certification does not fall under FDA’s accredited third-party certification program, but can be a great verification tool for importers and a means for foreign suppliers to demonstrate compliance to their US clients.

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Hank Karayan
Global FSMA Program Director
t: +1 (201) 508-3000