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FSMA Preventive Controls & Food Safety Compliance Services

FSMA Compliance – Ready for U.S. Food Safety Standards?

🔹Understanding FSMA: Why It Matters

The Food Safety Modernization Act (FSMA) transformed U.S. food regulation from a reactive system to a preventive, risk-based approach. Under FSMA, food manufacturers are responsible for identifying hazards, implementing preventive controls, and maintaining documented food safety systems.

Foreign food facilities exporting to the United States must meet the same standards as domestic manufacturers. Non-compliance can lead to inspections, shipment refusals, import alerts, and loss of market access.

FSMA compliance is essential for long-term participation in the U.S. food market.

Our Specialized FSMA Services

Custom Food Safety Plan (FSP) Development: We create facility-specific plans that include Hazard Analysis, Preventive Controls (Process, Allergen, Sanitation, Supply-Chain), and Recall Plans.

PCQI Oversight: All plans are developed or overseen by a Preventive Controls Qualified Individual (PCQI) to meet 21 CFR 117.126 requirements.

Hazard Analysis & Risk Assessment: Deep-dive identification of biological, chemical (including radiological), and physical hazards specific to your ingredients and equipment.

Environmental Monitoring Programs (EMP): Strategic “swab-a-thon” planning and pathogen tracking for facilities producing ready-to-eat (RTE) foods.

Supply Chain Programs: Helping receiving facilities verify their global suppliers through audits, sampling, and record reviews.

MoCRA & FSMA Synergy: If you manufacture “Edible Cosmetics” or ingestible beauty products, you may now fall under dual oversight. We help you bridge that gap.

🔹 Who This Service Is For

Our FSMA compliance services are designed for:

✔ Food and spice manufacturers
✔ Herbal and botanical processors
✔ Tea and beverage producers
✔ Ready-to-eat food exporters
✔ Ingredient suppliers
✔ Private-label food brands

If your facility processes, packs, or holds food for the U.S. market, FSMA applies to your operations.

🔹 Food Safety Plan Development

We assist in developing compliant Food Safety Plans aligned with FSMA requirements.

Includes:

✔ Hazard analysis
✔ Preventive control identification
✔ Monitoring procedures
✔ Corrective action plans
✔ Verification activities
✔ Recordkeeping systems

A properly designed plan reduces regulatory risk

🔹 Preventive Controls Implementation

We guide you in implementing practical preventive controls across your operations.

Includes:

✔ Process controls
✔ Sanitation controls
✔ Supply-chain controls
✔ Allergen controls
✔ Recall readiness planning

We focus on realistic, scalable systems.

🔹Supplier & Supply Chain Verification

FSMA requires verification of ingredient suppliers.

We support:

✔ Supplier approval programs
✔ Risk assessments
✔ Documentation systems
✔ Audit preparation
✔ Importer coordination

Strong supply-chain controls improve compliance stability.

🔹Foreign Supplier Verification Program (FSVP) Support

For importers and exporters, we assist with FSVP compliance.

Includes:

✔ Hazard evaluations
✔ Supplier verification plans
✔ Record maintenance
✔ Import coordination
✔ Regulatory readiness

This helps prevent import detentions.

🔹Our Advantage

Why Choose FDA Consults ?

✔ U.S.-Based Regulatory Consultants
✔ Experience with Cosmetics Direct Portal
✔ International Export Expertise
✔ Technical Submission Accuracy
✔ Ethical, Transparent Guidance
✔ Personalized Support

Let’s Work Together

If you are preparing to enter the U.S. market or need reliable FDA registration and U.S. Agent support, our team is ready to assist you. Contact FDA Consults today to discuss your compliance needs.

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🔹 Compliance Disclaimer

FDA Consults is an independent consulting firm and is not affiliated with or endorsed by the U.S. Food and Drug Administration. Our services do not constitute approval, certification, or legal representation.