The U.S. Food and Drug Administration (FDA) recently released a draft guidance detailing its implementation of Remote Regulatory Assessments (RRAs). The draft, “Conducting Remote Regulatory Assessments: Questions and Answers,” outlines FDA’s use of RRAs to continue regulatory oversight both during and beyond the COVID-19 pandemic. The guidance states that RRAs, which allowed FDA to assess an establishment’s compliance amid travel restrictions, have proven valuable and are “in the interest of the public health.” FDA has determined that continued use of RRAs will be beneficial post-pandemic and across all FDA-regulated industries.

While RRAs are voluntary in certain circumstances, they are mandatory in others. For example, RRAs are mandatory regarding the Foreign Supplier Verification Program (FSVP) for U.S. food importers. Because record-keeping is an essential element of FSVP compliance, establishments must ensure that the required FSVP records are properly maintained, in English, and can be quickly made available to FDA when it is implementing RRAs to assess their compliance.

Importing businesses are not considered a facility, unless they manufacture, process, pack or hold food as well. But in that case FDA would inspect for compliance with the Supply Chain Program under 117 (equivalent to FSVP for food facilities), not FSVP for US importers.

FSVP Record Reviews

FDA describes RRAs as “a category of activities for which FDA may use different terminologies, but that are all considered to be types of RRAs, including ‘remote interactive evaluations and ‘remote record reviews.’”

The FSVP rule requires documentation that demonstrates FDA food safety compliance for each food imported per supplier. The FSVP must be updated at least every 3 years, or whenever significant supplier/product information changes, such as the facility’s address or when a new ingredient or process is incorporated thus affecting the hazard analysis or other evaluations in the FSVP.

FDA determines the specified timeframe for an establishment to submit records for a mandatory RRA on a case-by-case basis. However, the Federal Food, Drug, and Cosmetics (FD&C) Act requires importers to provide FSVP records “promptly to the FDA upon request.” When the FDA makes a written request for records, the records must be sent electronically or in another way that allows prompt delivery. During RRA’s the FDA Compliance Officer will request that the records be submitted via the FSVP Importer Portal for FSVP Records Submission. Importers will be prompted to create an account and upload the requested FSVP records to the portal. The records must be organized and properly identified. At other times, they could be submitted via email.

Just as FDA is legally authorized to obtain records remotely, FDA can legally request FSVP physical records be provided when inspecting in person at the importer’s place of business.

Penalties for FSVP Non-Compliance

If a U.S. importer does not respond to FDA’s request for FSVP records, FDA may refuse their food imports at the U.S. port of entry (21 CFR 1.514(a)), and the importer may be in violation of section 805 of the FD&C Act. Actions including withdrawing participation and refusing to provide records to FDA are among the actions that FDA may deem as declining to participate in a mandatory RRA.

Further, if violations are found during an FSVP inspection, FDA will issue a Form 483, outlining the inspectional observations. If an importer fails to respond and take corrective action within 15 days, FDA will publicly post a Warning Letter, which can then escalate to receiving a public Import Alert 99-41.

Once an Import Alert is issued, FDA will detain an importer’s violative food shipments without physical examination. This effectively can shut down an importer’s business.

Registrar Corp’s Compliance Monitor’s Solution for FSVP Records

RRAs increase the rate at which FDA can inspect U.S. importers for FSVP compliance. If FDA has not yet conducted a remote assessment of your firm, you still have time to prepare your FSVP records. Registrar Corp’s Compliance Monitor can help you monitor a supplier’s compliance with FDA and to organize and maintain your FSVP records so they are easily accessible and inspection-ready.

Compliance Monitor’s Document Management System allows you to:

• Digitally store your suppliers’ compliance documentation in one place
• Set record validity dates to ensure you promptly request updated food safety documents from your suppliers when they are no longer valid and act promptly on corrective actions as needed
• Quickly send electronic documents to FDA to comply with remote record reviews
• Access files anytime on Compliance Monitor’s cloud-based platform
• Filter files to quickly access specific document types and identify actionable items so that you may correct any gaps in your records.