SQF Edition 10 · FDA FSMA
FDA Compliance Integration: Align SQF With FSMA and FDA Regulations
FDA compliance integration brings SQF, FSMA and FDA expectations into one system. Instead of maintaining duplicate procedures, your SQF-certified facility gets unified documentation that is both audit-ready and inspection-ready.
One system, fully aligned
Audit-Ready and Inspection-Ready in One System
Harmonized SQF + FSMA
SQF Edition 10 and FSMA in one cohesive system.
FDA inspection ready
Structured, audit-ready documentation and records.
Import & export compliance
Requirements covered for global operations.
Our FDA integration services
SQF and FDA Compliance Integration Services
01
FSMA & SQF Alignment Program
✓ Gap analysis between SQF and FSMA (Preventive Controls, HARPC, FSVP)
✓ Preventive controls integrated into HACCP plans
✓ Unified documentation for SQF and FDA
✓ Redundant procedures consolidated
02
FDA Inspection Preparedness
✓ Mock FDA inspections
✓ Coaching on records, responses and facility conditions
✓ FDA Form 483 response and remediation support
✓ Facility-specific inspection playbooks
03
Import & Export Compliance
✓ FSVP development and implementation
✓ Strategies to prevent FDA detention and import alerts
✓ Export documentation for U.S. and destination countries
✓ Customs documentation and regulatory coordination
Service options & pricing
FDA Compliance Integration Pricing
SQF sites adding FSMA
Basic Alignment
$4,500
One-time
✓ SQF and FSMA documentation harmonization
Get startedNew FDA-regulated facilities
Full Integration
$10,000
One-time
✓ Complete system overhaul
✓ Team training
Custom packages are available for multi-facility operations.
Key integration focus areas
Where SQF and FDA Requirements Meet
FSMA preventive controls
Integrated into your SQF food safety system.
Hazard analysis alignment
HACCP and HARPC harmonized.
Supplier verification
SQF supplier programs aligned with FSVP.
Documentation systems
Unified, audit- and inspection-ready records.
Inspection readiness
Prepared for FDA inspections and regulatory audits.
Less duplication
One system instead of two, with a lighter compliance burden.
FDA integration FAQs
Questions About SQF and FDA Compliance
Does SQF certification mean we meet FDA requirements?
Not automatically. SQF and FSMA overlap, but preventive controls, HARPC and FSVP requirements need to be built into your system. Our alignment program closes those gaps.
Can you help us respond to an FDA Form 483?
Yes. FDA inspection preparedness includes Form 483 response, corrective actions and remediation strategies.
Do you help importers with FSVP?
Yes. Trade Compliance covers FSVP development and import/export program setup.
Eliminate duplication. Achieve full compliance.
Why maintain separate systems when one well-designed system can meet all requirements? Book a free alignment consultation.
Food Safety Systems is an independent consulting provider and is not affiliated with or endorsed by the Safe Quality Food Institute (SQFI). Read our disclaimer.
