HACCP Regulatory Compliance Audits

Prepare With Confidence. Perform With Accuracy. Pass With Ease.

Requirement Overview

Regulatory agencies expect HACCP systems to be fully implemented, verifiable, and supported by complete documentation. Whether you are regulated by USDA FSIS, FDA, or a local health department, a compliance audit can uncover gaps that impact your certification, your customers, and your brand.

Our Regulatory HACCP Compliance Audit Services help you identify risks, correct weaknesses, and ensure your facility is fully prepared for inspections, audits, and regulatory visits.

Why Regulatory HACCP Audits Matter

Auditors examine far more than your HACCP Plan—they evaluate your monitoring, verification, corrective actions, training records, sanitation controls, traceability, and real-time operational practices.

A pre-inspection audit ensures no surprises when regulators arrive.

Our HACCP Compliance Audit Services

USDA HACCP Verification Audits

USDA FSIS–style HACCP verification audits provide an objective assessment of regulatory compliance and system effectiveness.

We conduct comprehensive verification audits that include:

  • ✓ Hazard Analysis and CCP Review
    Evaluation of hazard identification, CCP determination, critical limits, and scientific justification.
  • ✓ Monitoring, Recordkeeping, and Corrective Action Verification
    Review of HACCP records to confirm monitoring is complete, corrective actions are appropriate, and documentation meets FSIS expectations.
  • ✓ Sanitation SOP (SSOP) Assessment
    Verification of SSOP design, implementation, pre-operational activities, and ongoing sanitation controls.
  • ✓ Pre-Shipment Review Evaluation
    Assessment of pre-shipment review procedures to ensure product disposition decisions are properly verified and documented.
  • ✓ Plant Operations and Employee Practice Observation
    On-floor observations confirm procedures are executed as written and employees follow food safety requirements.
  • ✓ Microbiological Testing and Sampling Program Review
    Evaluation of pathogen testing, sampling frequency, trending, and response to results.

You receive a detailed audit report outlining findings, nonconformities, risk observations, and clearly defined corrective actions—supporting continuous improvement, regulatory readiness, and audit confidence.

FDA HACCP Compliance Audits

FDA HACCP compliance evaluations provide a structured assessment of plan adequacy, implementation, and inspection readiness.

For FDA-regulated facilities, our evaluations include:

  • ✓ HACCP Plan Structure and Completeness
    Review of plan components to ensure all required elements are present, current, and properly organized.
  • ✓ CCP Justification and Scientific Support
    Verification that CCPs, critical limits, and controls are supported by scientific or regulatory justification.
  • ✓ Prerequisite Program Review
    Evaluation of sanitation, allergen control, supplier approval, training, and other foundational programs supporting HACCP.
  • ✓ Recordkeeping and Verification Review
    Assessment of monitoring, verification, corrective action, and validation records for completeness and consistency.
  • ✓ FDA Inspection Readiness Scoring
    Readiness assessment highlights gaps, risk areas, and likely inspection focus points.
  • ✓ FSMA Preventive Controls Alignment
    HACCP programs are reviewed for alignment with applicable FSMA Preventive Controls requirements.

This evaluation prepares your facility for routine FDA inspections, targeted visits, and compliance reviews—supporting regulatory confidence, reduced inspection risk, and continuous improvement.

Pre-Inspection Audits for Regulatory Agencies

Comprehensive internal audits mirror the expectations of multiple regulatory authorities and evaluate real-world implementation of your food safety systems.

FDA Pre-Inspection Audits include:

  • ✓ Flow Diagram and Hazard Analysis Validation
    Process flows and hazard analyses are reviewed for accuracy, completeness, and scientific justification.
  • ✓ Monitoring and Verification Evaluation
    CCP and preventive control monitoring, verification activities, and records are assessed for compliance.
  • ✓ Corrective Action Evaluation
    Deviation handling, root cause analysis, and corrective actions are reviewed for effectiveness.
  • ✓ Supporting Scientific Documentation Review
    Validation studies, references, and technical justifications are verified for regulatory adequacy.
  • ✓ Personnel Interviews and Floor Verification
    Employee interviews and in-plant observations confirm that written programs match actual practices.

USDA FSIS Pre-Inspection Audits include:

  • ✓ HACCP System Reassessment Review
    Annual and event-driven reassessments are evaluated for completeness and regulatory alignment.
  • ✓ SSOP Compliance Evaluation
    Sanitation SOPs are reviewed against operational execution and recordkeeping requirements.
  • ✓ Operational Sanitation Verification
    Pre-operational and operational sanitation practices are verified through records and observation.
  • ✓ Record Completeness Review
    HACCP, SSOP, and supporting records are checked for accuracy, completeness, and retention compliance.
  • ✓ Noncompliance Tracking and Root Cause Assessment
    NR trends, corrective actions, and preventive measures are evaluated for effectiveness.

Local Health Department Pre-Audits include:

  • ✓ Food Code Compliance Review
    Facility practices are evaluated against applicable local and state food code requirements.
  • ✓ Temperature and Holding Practice Checks
    Cold holding, hot holding, cooling, and reheating controls are verified for compliance.
  • ✓ Cleaning and Sanitation Program Assessment
    Sanitation procedures, frequencies, chemicals, and verification activities are reviewed.
  • ✓ Employee Hygiene and Handling Evaluations
    Personal hygiene, glove use, handwashing, and food handling practices are assessed.

Each audit concludes with a prioritized corrective action list, clear risk-based findings, and recommended timelines—supporting inspection readiness, regulatory confidence, and continuous improvement.

Mock Recall + Traceability Testing

Mock recall and traceability audits are essential for testing your system’s readiness and ensuring compliance with GFSI and regulatory expectations.

Our traceability audits include:

  • ✓ Ingredient-to-Finished-Goods Traceability Review
    Full verification of traceability from raw materials through finished products.
  • ✓ 1-Up/1-Down Supplier and Customer Linkage Checks
    Ensures accurate connection between suppliers and customers for all lots.
  • ✓ Document Retrieval Stress Testing
    Confirms your system can quickly retrieve required documentation during audits or recalls.
  • ✓ Lot Coding and Batch Control Evaluation
    Checks that lot codes and batch tracking enable precise product identification and segregation.
  • ✓ 2-Hour Recall Performance Testing
    Simulates rapid product recall to test effectiveness and team response.
  • ✓ Report of Recall Execution Effectiveness
    Provides a detailed summary of findings, gaps, and recommended improvements.

Mock recalls are required by GFSI schemes and are now routine expectations during FDA inspections, helping you maintain compliance, protect consumers, and strengthen operational readiness.

Deliverables You Receive

Comprehensive audit deliverables provide actionable insights and guidance to strengthen your food safety program.

Our audit documentation includes:

  • ✓ Full Regulatory-Style Audit Report
    Complete documentation of findings, observations, and compliance gaps.
  • ✓ Nonconformity List with Severity Ratings
    Highlights areas of concern with clear severity categorization for prioritization.
  • ✓ Corrective Action and Preventive Action (CAPA) Plan
    Provides step-by-step guidance to address nonconformities and prevent recurrence.
  • ✓ Updated HACCP Documentation (If Requested)
    Aligns records with audit findings and ensures ongoing compliance.
  • ✓ Inspection Readiness Scorecard
    Measures facility preparedness for regulatory inspections and customer audits.
  • ✓ Recall Performance Evaluation Documentation
    Demonstrates system effectiveness during mock recall exercises.
  • ✓ Recommended Timelines and Risk-Based Priorities
    Provides actionable next steps with prioritization based on risk assessment.

These deliverables ensure your facility has a clear roadmap to improve food safety performance, maintain compliance, and support audit readiness.

Who This Service Is Ideal For

Our services are suitable for:

  • ✓ USDA FSIS Establishments
  • ✓ FDA-Regulated Facilities
  • ✓ GFSI-Certified Operations
    Includes SQF, BRCGS, and FSSC 22000-certified facilities.
  • ✓ Importers Needing FSVP + HACCP Alignment
  • ✓ Facilities Preparing for Inspections
    Covers both announced and unannounced visits.
  • ✓ Companies Seeking Lower-Risk Audit Pathways

Be Inspection-Ready at Any Moment

Regulatory readiness isn’t optional — proactive preparation is essential. A structured HACCP compliance audit identifies gaps before inspectors or auditors do, helping protect your certification, brand, and customers while ensuring regulatory compliance and audit confidence.

Schedule Your HACCP Compliance Audit Today

Whether you are preparing for an upcoming inspection, testing your traceability system, or strengthening daily HACCP execution — we can help.

  • ✓ Request a USDA or FDA Pre-Inspection Audit
  • ✓ Book a Mock Recall + Traceability Test
  • ✓ Strengthen Your Compliance Before the Next Regulatory Visit

Be confident. Be prepared. Be audit-ready—every single day.

GET STARTED NOW

This document is intended for internal training and compliance purposes only and is provided for informational use. It is not affiliated with or endorsed by any official HACCP certification body.

For guidance and compliance requirements included in our services, we follow recognized HACCP standards and applicable regulatory agencies.