Food Defense Gap Assessment Services
Powered by Consultare Inc. Group — A Compliance Company
Delivered via the IntelComp Compliance Platform | Performed by Verified Service Providers
Consultare Inc. Group helps food manufacturers, processors, and distributors comply with the FDA’s Food Defense requirements under 21 CFR Part 121 (Intentional Adulteration Rule). All services are delivered by Verified Service Providers — experienced food safety professionals and certified FSMA consultants trained in food defense risk analysis, vulnerability assessments, and mitigation strategies. We identify gaps in your Food Defense Plan, assess your mitigation strategies, and help ensure your facility is audit-ready and compliant with FDA and GFSI standards.
PACKAGE 1
Basic Food Defense Gap Assessment (Vulnerability Screening)
Ideal For:
-
• Small and medium-sized facilities required to comply with the IA Rule
• Food manufacturers needing a basic Food Defense Plan review
Scope Includes:
-
• Kickoff session & scope alignment (FSVP or registered facility)
• Evaluation of current Food Defense Plan and mitigation strategies
• High-level review of actionable process steps and vulnerabilities
• Gap Summary Report and prioritized next steps
• High-level POAM (Plan of Action & Milestones)
Timeline:
-
• 2–3 Weeks
Estimated Price:
-
$3,500 – $5,000
(Pricing based on site complexity and documentation maturity)
PACKAGE 2
Standard Food Defense Gap Assessment (Full IA Rule Evaluation)
Ideal For:
-
• Facilities covered by FDA’s Intentional Adulteration Rule
• Organizations needing a full vulnerability assessment and mitigation strategy review
Scope Includes:
-
• Evaluation of all applicable 21 CFR 121 requirements
• Assessment of key activities (e.g., mixing, batching, secondary packaging)
• Review of mitigation strategies, monitoring, corrective actions, and training records
• Interviews with Food Defense Qualified Individuals (FDQIs) and plant managers
• Control-by-control scoring and detailed Gap Assessment Report
• Risk-based POAM with mitigation plan improvement roadmap
Timeline:
-
• 4–6 Weeks
Estimated Price:
-
$8,500 – $12,500 (Pricing based on site complexity and documentation maturity)
PACKAGE 3
Premium Food Defense Readiness & Audit Simulation
Ideal For:
-
• FDA-regulated facilities preparing for inspections or third-party audits
• Companies seeking a full mock audit simulation and detailed compliance coaching
Scope Includes:
-
• Complete evaluation of Food Defense Plan per IA Rule
• On-site or virtual walk-through of vulnerable process steps
• Review of mitigation strategy effectiveness and monitoring records
• Mock audit simulation using FDA inspection methodology
• Food Defense Scorecard and Remediation Roadmap
• Executive Management Report
• 90-Day Post-Assessment Support, including:
-
∘ Coaching for FDQI roles
∘ Recordkeeping and training review
∘ Documentation guidance
- ∘ Coaching for FDQI roles ∘ Recordkeeping and training review ∘ Documentation guidance
Timeline:
-
• 6–8 Weeks
Estimated Pricing:
-
$15,000 – $22,000 (Pricing based on site complexity and documentation maturity)
ADD-ON SERVICES (Provided by Verified Food Safety Professionals)
| Service | Description | Fee |
|---|---|---|
| Ongoing Compliance Coaching | Monthly food defense support for plan updates, records, training | Custom Quote |
| Documentation Development | Creation or revision of Food Defense Plans, mitigation records, SOPs | Custom Quote |
| IntelComp Platform License | Digital platform for managing mitigation strategies and documentation | Custom Quote |