FSSC 22000 & FDA Compliance Integration Services

Seamlessly Align FSSC 22000 with FSMA & FDA Regulations

Operating an FSSC 22000-certified facility and navigating FDA compliance? Our integration services bridge the gap between FSSC 22000, FSMA, and FDA regulations, enabling you to meet all requirements without duplicating systems or documentation.

We help you:

Harmonize FSSC 22000 and FSMA requirements into a single efficient system

Simplify FDA inspections through audit-ready documentation and protocols

Navigate complex import/export rules for global trade compliance

Our FDA Compliance Integration Services

1. FSMA/FSSC 22000 Alignment Program

  • Perform a comprehensive gap analysis between your FSSC 22000 system and FSMA rules (Preventive Controls, HARPC, FSVP)

    Create a unified documentation system that satisfies both FSSC and FDA expectations

    Integrate preventive controls into existing HACCP-based systems

2. FDA Inspection Preparedness

  • Conduct mock FDA inspections led by former regulatory professionals

    Assist with responses to FDA Form 483 observations and warning letters

    Provide FDA inspection playbooks tailored for FSSC 22000-certified facilities

3. Import/Export Compliance

  • Develop and maintain Foreign Supplier Verification Programs (FSVP)

    Implement strategies to prevent FDA import alerts

    Support documentation for customs clearance and foreign regulatory compliance

Service Options & Pricing

Service Description Investment Action
Basic Alignment Documentation harmonization for facilities adding FSMA $4,500
Full Integration Comprehensive system alignment with team training $10,000
Trade Compliance Import/export program development and documentation $6,000

Custom packages available for multi-facility operations.

Why Choose Our Integration Services?

  • ✓ Dual-Expertise Team – FSSC 22000 professionals + former FDA regulators

    ✓ No Redundancy – Smart integration saves 30–50% in compliance time and cost

    ✓ Audit-Ready Systems – Built to withstand real-world FDA and certification audits

One System. All Compliance.

  • Book Your Free Compliance Alignment Consultation
"Why maintain separate systems when a single, well-designed framework meets both FSSC 22000 and FDA expectations?"