Pre-FDA Inspection Gap Assessment
(Philippine Food and Beverage Facilities)
Pre-Inspection Compliance Review and Mock Audit
This service provides a structured, inspection-style preparation modeled after real FDA protocols. Tailored for Philippines-based food facilities whose products enter the U.S. market and subject to the applicable U.S. regulations, including FSMA, HARPC, cGMP, and 21 CFR Part 117, this engagement simulates the FDA inspection experience, pinpoints compliance gaps, and equips your team with actionable strategies prior to an FDA visit.
Scope of Work
Pre-Audit Documentation Review
• Review food safety programs (HACCP, HARPC, PCQI-led controls, SOPs, and monitoring records)
• Verify current FDA registration and applicable third-party certifications
• Assess documentation against relevant FDA regulations (21 CFR 117, 120, 121, or others based on facility 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 |
|---|---|---|
| Basic Remote Readiness Review | Document review with gap report and checklist only (no walkthrough) | $1,300 |
| Standard Remote Inspection Prep | Document review + virtual walkthrough + interviews + final report | $1,500 |
| Onsite Inspection Simulation | Onsite facility walkthrough + document review + interviews + final report | $2,500 (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 – $1,200.00 per product
(Includes full HACCP plan, hazard analysis, CCPs, and validation)
• On-Site Support Visit (w/ in-person implementation coaching) – $800.00/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 foreign food facilities subject to inspection
• Philippines-based 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