Pre-FDA Inspection Compliance Review & Facility Gap Assessment – Dietary Supplements

Pre-Inspection Compliance Review & Mock Audit

This service provides a detailed, audit-style FDA inspection preparation modeled after actual FDA protocols. Designed for U.S. and foreign facilities regulated under FSMA, cGMP, HARPC, or dietary supplement regulations, this preparation simulates the inspection experience, identifies compliance gaps, and supports your team with corrective action strategies before an FDA inspection.

Scope of Work

Pre-Audit Documentation Review

• Review of existing food safety programs (HACCP, HARPC, PCQI, SOPs, and Records)
• Verification of FDA registration and applicable certifications
• Evaluation of documentation under 21 CFR Parts 117, 120, 111, or other applicable regulations

Facility Walkthrough (Remote or Onsite)

• Conduct a mock inspection simulating FDA investigator protocols
• Observe hygiene and employee practices for compliance with cGMP
• Assess equipment conditions, sanitation, and preventive maintenance
• Evaluate labeling practices, storage conditions, and pest control measures
• Review production flow and material handling for cross-contamination risks
• Examine sanitation Standard Operating Procedures (SOPs) for adequacy and implementation
• Identify potential issues at control points throughout the facility

Compliance Interviews and Staff Preparedness Check

• Mock Interview of key personnel for regulatory awareness and responsibilities
• Evaluate response readiness for FDA Form 482 (Inspection Notice) and 483 (Observations)
• Assess understanding of recall plans, traceability systems, complaint handling, and food defense

Gap Analysis Report

• Summarized findings categorized by risk level and regulatory priority
• Actionable recommendations for corrective measures and compliance alignment
• Suggested timelines for closure of identified gaps
• Optional post-audit support for implementing corrective actions

Deliverables

• Customized FDA Inspection Readiness Checklist • Facility Inspection Gap Analysis Report (PDF) • Corrective Action Plan (CAP) Recommendations • Optional: Staff Readiness Training Slides • 30-Day Email/Chat Compliance Support

Fees and Subscriptions

All prices in USD. Final rates depend on facility size, location, and scope.

Service Tier	Description	Fee
Basic Remote Readiness Review	Document review with gap report and checklist only (no walkthrough)	$1,500	Purchase
Standard Remote Inspection Prep	Document review + virtual walkthrough + interviews + final report	$2,500	Purchase
Onsite Inspection Simulation	Full onsite audit: document review, walkthrough, interviews, and training	$4,900 (plus travel expenses)
Multi-Facility Bundle	For companies with 2–3 locations, includes consolidated audit and reporting	Custom Quote (starts at $7,000)

Add-On Services (Optional)

Add-On	Fee
SOP Customization & Gap Remediation Plan	$500 per set of 5 SOPs
Recall Plan Development & Effectiveness Testing	$2,500
PCQI Consultation (1-on-1)	$250/hour
FSVP Integration & Supplier Risk Assessment	Custom Pricing
Post-Audit Corrective Action Monitoring (30 Days)	$500

Ideal For:

• FDA-registered food, supplement, and packaging facilities • Importers and co-packers subject to FDA inspection • Foreign suppliers exporting to the U.S. • Facilities preparing for random, for-cause, or follow-up FDA audits

Other Terms

• Travel and accommodation (for onsite services) billed separately and pre-approved