Pre-FDA Inspection Compliance Review & Facility Gap Assessment – Food and Beverages

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 human/animal food 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 existing food safety programs (HACCP, HARPC, PCQI-led programs, SOPs, and supporting records)
• Verify FDA registration status and applicable third-party certifications
• Evaluate documentation against applicable FDA regulations (21 CFR Parts 117, 120, 121, or others as relevant to the facility’s operations)

Facility Walkthrough (Remote or Onsite)

• Conduct a mock inspection simulating FDA investigator protocols
• Observe hygiene practices and employee behaviors for cGMP compliance
• Assess equipment condition, sanitation practices, and preventive maintenance records
• Review product labeling, material storage, and pest control activities
• Evaluate production flow and material handling for potential cross-contamination risks
• Examine sanitation SOPs for adequacy, implementation, and documentation
• Identify issues at key control points across the facility

Compliance Interviews and Staff Preparedness Check

• Conduct mock interviews with key personnel to assess regulatory awareness and role-specific responsibilities
• Evaluate preparedness for FDA Form 482 (Notice of Inspection) and Form 483 (Inspection Observations)
• Assess familiarity with recall procedures, product traceability, customer complaint handling, and food defense protocols

Gap Analysis Report

• Categorize findings based on risk level and regulatory impact
• Provide specific, actionable recommendations for corrective measures
• Suggest timelines and priority levels for resolving identified compliance gaps
• (Optional) Provide post-audit technical guidance to support corrective action implementation

Deliverables

• Pre-FDA Gap Assessment and Mock Inspection Report
• Customized FDA Inspection Readiness Checklist
• Formal Facility Inspection Gap Analysis Report (PDF), with findings and recommendations

Fees and Subscriptions

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

Service Tier	Description	Fee
Standard Remote Inspection Prep	Document review + virtual walkthrough + interviews + final report	$4,750	Purchase
Onsite Inspection Simulation	Onsite facility walkthrough + document review + interviews + final report	$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)

Notes:

• Miscellaneous fees (i.e., travel, meals, lodging) are excluded from the price quote.
• Onsite delivery will require advance coordination for access, safety orientation, and logistical arrangements.
• The assessment should be scheduled prior to the FDA's onsite visit to support inspection readiness and mitigate potential compliance risks.

Add-On Services (Optional)

• Gap Assessment Corrective Action Support – starts at $75.00 per document
• HACCP/Food Safety Plan Development – $2,200.00 per product (Includes full HACCP plan, hazard analysis, CCPs, and validation)
• On-Site Support Visit (w/ in-person implementation coaching) – $1,200.00/day + miscellaneous

Gap Assessment and Internal Audit Agenda Samples

Itinerary for facilities availing the Onsite Tour option — 5-day Engagement:

Day	Agenda Coverage
0	Travel to Facility
1	Facility Tour and Initial Observations (General Operations, Plant Layout, Infrastructure, Personnel Practices, Production Areas, Storage, Maintenance Areas, Waste Management, External Grounds)
2	Facility Observation Conclusion (Transport Areas, Chemical Storage, Staff Amenities, Cross-Contamination Risks), Document Review Kick-off
3	Document and Record Review (Food safety programs, GMPs, SOPs, traceability, sanitation, training), Interviews with Key Personnel (QA, Sanitation, Maintenance)
4	Internal Mock Inspection Activities; Final Document Checks; Preliminary Findings
5	Closing Meeting (Presentation of key findings, discussion of prioritized gaps and regulatory risks, next steps); Return from Facility

Itinerary for facilities availing the Remote option — 5-day Engagement:

Day	Agenda Coverage
1	Opening Meeting via Video Call (Scope confirmation, introduction to assessment process); Virtual Facility Tour Review (Client-provided videos, photos, or live virtual walkthrough: facility layout, processing, quality control, storage, receiving, dispatch areas, and staff amenities)
2 – 3	Document and Record Review (Procedures, SOPs, Forms, Logs); Review of Key Operational Programs (food safety programs, logs, supplier and sanitation records, US FDA registration documentation)
4	Virtual Interviews (QA personnel, Sanitation, Maintenance, Operations Managers); Preliminary Findings Discussion
5	Closing Meeting (Presentation of key findings, discussion of prioritized gaps and regulatory risks, next steps)

Ideal For:

• FDA-registered food 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