FDA Third-Party Certification Program: How Accredited Audits Expedite US Food Imports

The FDA's Accredited Third-Party Certification Program is one of the most forward-looking provisions of FSMA, creating a structured system through which foreign food facilities can be audited and certified by FDA-recognized auditing organizations. Established under Section 808 of the FD&C Act (as added by Section 307 of FSMA) and implemented through 21 CFR Part 1, Subpart M, the program creates a three-tier framework: the FDA recognizes accreditation bodies, which accredit certification bodies, which audit and certify foreign food facilities and their products. Certification under this program serves two critical purposes — it enables importers to participate in the Voluntary Qualified Importer Program (VQIP) for expedited import entry, and it allows the FDA to require certification as a condition of import for specific foods from specific countries.

How the three-tier accreditation structure works

The program operates through a layered accreditation and certification structure. At the top, the FDA recognizes accreditation bodies — organizations with the competence and capacity to evaluate and accredit certification bodies. Recognized accreditation bodies then accredit third-party certification bodies — auditing organizations that have demonstrated they meet FDA requirements for conducting food safety audits of foreign facilities. These accredited certification bodies conduct on-site audits of foreign food facilities and, based on the audit findings, issue certifications attesting that the facility and its products meet applicable FDA food safety requirements. The certifications are submitted to the FDA electronically and become part of the facility's compliance record.

Regulatory versus consultative audits

The program distinguishes between regulatory audits and consultative audits. A regulatory audit is conducted for the purpose of issuing a certification that will be used for VQIP eligibility or mandatory certification — it must be unannounced, must cover all applicable FDA food safety requirements, and the results must be reported to the FDA. A consultative audit is a voluntary, announced audit that a facility may request to evaluate its compliance status and identify areas for improvement before undergoing a regulatory audit. Consultative audit results are not reported to the FDA and cannot be used for certification purposes. Foreign manufacturers should consider requesting a consultative audit as a preparatory step before committing to the regulatory audit process.

Certification for VQIP eligibility

The primary benefit of accredited third-party certification for most foreign food facilities is enabling their US importers to participate in VQIP. To qualify for VQIP, an importer must demonstrate that the food being imported comes from a facility certified under the FDA's accredited third-party certification program. VQIP participation provides expedited FDA review and release of import entries, which translates to faster clearance at US ports and reduced risk of routine examination or detention. For high-volume importers, VQIP can provide significant operational and financial benefits by reducing port delays, demurrage charges, and supply chain uncertainty.

Mandatory certification under Section 303

Section 303 of FSMA gives the FDA authority to require, as a condition of admission, that an article of food imported into the United States be accompanied by a certification issued by an accredited third-party certification body. The FDA can impose mandatory certification when it determines that a food presents a threat of serious adverse health consequences or death to humans or animals, or when the FDA has refused admission of the food because it appears to be adulterated. When mandatory certification is imposed, any shipment of the affected food that does not carry a valid certification will be refused entry. This authority gives the FDA a powerful tool to address persistent food safety problems associated with specific foods from specific countries or regions.

How FDABridge helps with certification readiness

FDABridge ensures that your FDA facility registration, US Agent designation, and food safety documentation are current and accurate — the foundational compliance elements that accredited third-party certification bodies evaluate during their audits. While FDABridge does not conduct third-party audits, we prepare foreign food facilities for the audit process by ensuring all regulatory filings are in order. Visit fdabridge.com/food to learn about our food services or fdabridge.com/contact to discuss your certification readiness.