FDA Compliance Integration Services
Seamlessly Align SQF with FSMA & FDA Regulations
Aligned with Safe Quality Food Institute SQF Edition 10 and U.S. FDA FSMA Requirements
Operating an SQF-certified facility but struggling to align with FDA requirements? Our FDA Compliance Integration Services bridge the gap between SQF, FSMA, and FDA regulatory expectations—eliminating duplication while ensuring full compliance across all frameworks.
We design unified systems that satisfy both certification and regulatory requirements, allowing your operation to function efficiently under a single, integrated compliance structure.
One System. Fully Aligned. Audit & Inspection Ready.
We help you: ✓ Harmonize SQF Edition 10 and FSMA requirements into a single, cohesive system ✓ Prepare for FDA inspections with structured, audit-ready documentation and records ✓ Navigate import/export compliance requirements for seamless global operations
Our FDA Compliance Integration Services
1. FSMA & SQF Alignment Program
- • Comprehensive gap analysis between SQF systems and FSMA requirements (Preventive Controls, HARPC, FSVP)
- • Integration of preventive controls into existing HACCP-based food safety plans
- • Development of unified documentation that satisfies both SQF and FDA expectations
- • Elimination of redundant procedures through system consolidation
2. FDA Inspection Preparedness
- • Mock FDA inspections simulating real inspection scenarios
- • Inspection readiness coaching focused on records, personnel responses, and facility conditions
- • Support for FDA Form 483 response, corrective actions, and remediation strategies
- • Development of facility-specific FDA inspection playbooks
3. Import & Export Compliance
- • Foreign Supplier Verification Program (FSVP) development and implementation
- • Import compliance strategies to prevent FDA detention and import alerts
- • Export documentation alignment with U.S. and destination country requirements
- • Support for customs documentation and regulatory coordination
Service Options & Pricing
| Service | Description | Investment | Action |
|---|---|---|---|
| Basic Alignment | Documentation harmonization for SQF sites adding FSMA | $4,500 | Subscribe |
| Full Integration | Complete system overhaul and training for new FDA-regulated facilities | $10,000 | Subscribe |
| Trade Compliance | Import/export program setup for importers and exporters | $6,000 | Subscribe |
Custom packages available for multi-facility operations
Program Structure
Services are tailored to your facility operations, regulatory exposure, and supply chain complexity. Engagements may include system alignment, full regulatory integration, or targeted support for FDA inspections and import/export compliance.
