By Nick Lung    Photo：CANVA

I. FSVP Regulatory Framework and Enhanced Importer Obligations

FSVP is a system established under the Food Safety Modernization Act (FSMA) for imported food. It requires importers to verify and control their foreign suppliers to ensure that imported food meets U.S. food safety requirements during manufacturing, packaging, storage, and transportation and is not adulterated or mislabeled.

According to the final rule, when importing food into the United States, importers must provide basic importer information, such as name, email address, and a Unique Facility Identifier (UFI), on customs declarations. FDA accepts the DUNS number as a valid UFI.

Importers who are also food manufacturers and must comply with preventive controls regulations may sometimes choose to substitute their preventive controls requirements for some FSVP requirements. However, they must be mindful of the regulatory requirements and applicable conditions.

In addition, the FDA will release final guidance in 2023, clarifying details such as the definition of an importer, scope of compliance, verification responsibilities, and recordkeeping requirements, to serve as guidance for law enforcement and industry.

II. Further Obligations for Key Personnel, Risk Analysis, and Supplier Assessments

Qualified Individual

Importers must designate a Qualified Individual (QI) with sufficient education, training, and experience to understand FDA regulations, interpret supplier records, and perform FSVP activities. This individual must be able to determine which hazards require control, which verification methods are appropriate, and assess supplier compliance.

• 【Hazard Analysis and Risk Assessment】

Importers must conduct hazard identification and risk assessments for the food they import, including biological, chemical, and physical hazards, and potentially allergens, pesticide residues, heavy metals, microorganisms, and cross-contamination. Furthermore, the assessment process should consider the supplier's previous compliance record, inspection failure history, recall history, previous FDA actions, and audit reports. Importers must design different levels of verification activities based on the level of risk and the supplier's reliability.

• 【Supplier Evaluation and Selection】

Before selecting a supplier, importers must conduct an assessment, which may cover the following aspects:

Food safety system, availability of third-party audit reports

Past import rejections, recalls, or other FDA administrative actions

Production site hygiene, quality control, and employee training records

Material sources, traceability mechanisms, and production process stability

Drawing/formula changes, processing equipment, and cleaning and sterilization procedures

If the supplier's conditions are subpar, importers may require more stringent verification controls (e.g., frequent spot checks, regular on-site audits, etc.).

III. Verification Activities, Corrective Actions, Reassessment, and Record Control

• 【Verification Activities】

Based on risk and supplier performance, importers must develop appropriate verification activities. Common methods include:

Onsite Audits: Conducting on-site inspections at supplier facilities, either in person or through a third party.

Sampling Inspections: Testing and inspecting samples from suppliers or imported batches.

Supplier Record Review: Reviewing production logs, quality control records, equipment maintenance records, etc.

Monitoring and Tracking: Supplier self-monitoring reports and trend analysis.

In certain circumstances, importers may rely on verification performed by a third party, such as a third-party auditing organization, as long as they obtain the report and relevant records.

• 【Corrective Actions】

If verification results indicate a supplier or food product non-conformity, importers must immediately initiate corrective procedures. Corrective actions should include:

Root cause investigation

Immediately isolating or suspending use of the batch

Requesting the supplier to make improvements/corrections

Tracking the impact and verifying the effectiveness of corrective actions

If a supplier fails to correct or frequently exhibits problems, the supplier may be removed from the market.

Corrective records must be fully maintained and available during audits.

•【 Reevaluation】

To maintain the effectiveness of the FSVP, importers should reevaluate and update the entire FSVP periodically (generally every three years) or as necessary (e.g., due to supplier changes, product formulation changes, issues, regulatory amendments, etc.).

Reevaluation should include the hazard analysis, supplier evaluation criteria, verification frequency and methods to ensure they remain appropriate, and any new risks.

• 【Recordkeeping and Document Management】

Importers must retain all documents and certifications related to the FSVP for at least two years (in some cases, longer periods may be required depending on regulations).

Required records include, but are not limited to:

Hazard analysis report and its basis

Supplier evaluation and approval documents

Verification activity reports (audits, sampling inspections, monitoring reports)

Corrective action reports and follow-up records

Reevaluation and revision records

Qualified Individual qualification and training records

Importer identity and UFI information

These records must be legible, traceable, complete, and readily available for FDA inspection.

IV. Practical Risks, Challenges, and Implementation Strategies for Taiwanese Businesses

• 【Common Risks and Challenges】

Lack of Supplier Transparency: Some overseas suppliers may not provide complete records or be willing to cooperate with audits, which can hinder the verification process.

Insufficient Resources and Cost Pressures: On-site audits, sampling, and document management can all incur costs, creating an additional burden, especially for small and medium-sized enterprises.

Inconsistent Compliance: If suppliers manufacture in different countries or regions and regulations vary significantly, it can be difficult to standardize standards.

Risk of Regulatory Changes and Updates: The US FDA may adjust its policies, issue new guidelines, or increase its inspection efforts, and importers must stay abreast of these changes.

Audit and Inspection Risks: Failure to provide evidence of compliance during an FDA inspection may result in warning letters, product detentions, and placement on the FSVP "Import Alert" list.

• 【How Taiwanese Businesses Can Implement and Strengthen Their Strategies】

Obtaining Professional Training/Certification: Participating in internationally recognized FSVP training (such as the FSPCA course) online or in-person and obtaining a certification will be persuasive when communicating internally and with customers.

Establish internal systems and SOPs first.

Develop standard operating procedures within the company, including hazard analysis procedures, supplier evaluation criteria, audit processes, corrective actions, and record management mechanisms, ensuring a systematic and operational system.

Manage suppliers in a tiered manner.

Categorize suppliers by risk level. Implement more verification measures and more frequent audits for high-risk suppliers, while streamlining procedures for low-risk suppliers (although credible evidence is still required).

Utilize reliable third-party resources/services.

If internal resources are limited, consider partnering with a professional third-party audit/verification firm to assist with on-site audits, inspections, and system reviews.

Maintain updates and internal education.

Regularly review regulations, guidelines (such as the latest FDA FSVP guidance), and industry best practices, and conduct retraining for employees and suppliers.

Risk control and response mechanisms.

Establish early warning mechanisms (e.g., increased supplier inspection exception rates, changes in supplier production, frequent customer complaints, etc.). Immediately initiate corrective and reassessment procedures if any anomalies are identified.

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