[J&B] FDA Onsite Audit Response Consulting Service for U.S. Exports

J&B Consulting is an FDA-focused regulatory consulting partner with over 15 years of experience supporting the U.S. market in the food, cosmetics, and dietary supplement industries.

We proactively manage regulatory risks that arise during U.S. export processes for Korean manufacturers and provide on-site, practical consulting to ensure compliance with U.S. importer and FDA requirements.

Products exported to the United States are subject to the Food Safety Modernization Act (FSMA). Under FSMA, U.S. importers are required to conduct Foreign Supplier Verification Program (FSVP) activities to verify that overseas manufacturing facilities comply with FDA regulations. As part of this process, the FDA compliance status of the manufacturing facility is a critical review point.

If FDA inspection materials are insufficient or facilities fail to meet FDA standards, exporters may face serious consequences such as shipment delays, import refusal, or termination of business relationships.

In particular, when a facility receives an official FDA Inspection Notice, it is essential to identify potential compliance issues in advance and to prepare and submit Corrective Action reports accurately and in accordance with FDA expectations after the inspection.

Without thorough preparation and a structured response strategy, even minor observations can escalate into further regulatory actions, including Warning Letters.

Based on extensive, hands-on FDA inspection response experience accumulated in the United States, J&B Consulting provides end-to-end support—from pre-inspection preparation to on-site inspection 대응 and post-inspection corrective actions.

Our Services

1. FDA Pre-Inspection Gap Assessment

We conduct a comprehensive review of your facility against FSMA and applicable FDA regulations to identify compliance gaps and potential regulatory risks in advance.

2. Gap Filling Consulting

For identified deficiencies, we provide practical improvement plans and preparation strategies aligned with FDA expectations to raise the facility’s compliance level in a meaningful and sustainable way.

3. FDA Inspection Support & Professional Interpretation (Optional)

During U.S. importer audits or FDA inspections, we can accompany your team on-site to interpret FDA questions accurately, identify regulatory intent, and support responses based on applicable regulations.

Interpretation without a clear understanding of FDA regulations and inspection procedures can lead to miscommunication and unnecessary risk. J&B Consulting provides consistent and accurate communication through professionals with direct FDA inspection experience.

This service is available upon request.

4. Corrective Action Follow-Up

When observations or potential violations arise, we provide follow-up advisory support on corrective action direction, documentation strategy, and FDA-compliant responses.

Recently, the FDA has continued to strengthen inspections and enforcement not only for food manufacturing facilities but also for cosmetic manufacturing facilities.

Accordingly, J&B Consulting offers comprehensive support—including pre-inspection preparation, on-site response, inspection accompaniment, and professional interpretation—to minimize U.S. export risks for our clients.

With deep regulatory expertise and extensive FDA inspection experience from our U.S. headquarters, J&B Consulting supports our clients through precise communication and strategic, helping them avoid unnecessary regulatory exposure and commercial losses.

Do you need a U.S. export facility audit or FDA inspection support?

Prepare accurately—with J&B Consulting.

jay@jnbfoodconsulting.com

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