If Jason Kwong Is Your FDA Inspector Here’s How to Stay Ready
Prepare for an FDA inspection by Jason Kwong with this guide covering common violations, FSVP and HACCP focus areas, and expert tips to stay compliant in 2025.
When the FDA comes knocking, every detail matters especially if the inspector is Jason Kwong. Known for his thorough assessments under the Foreign Supplier Verification Program (FSVP) and Seafood Hazard Analysis Critical Control Point (HACCP) regulations, Kwong's inspection history reveals patterns that food importers and processors cannot afford to overlook.
This article breaks down what Inspector Jason Kwong typically looks for, the most common citations issued under his watch, and a step-by-step guide for QA teams to proactively prepare. We’ll also show how using a tool like Atlas can give your compliance efforts a competitive edge.
Understanding Jason Kwong’s Inspection Focus
Inspector Jason Kwong’s reports frequently center around two critical areas:
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FSVP Violations
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Seafood HACCP Non-Compliance
Based on publicly available FDA 483s and warning letters, Kwong has consistently cited companies for:
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Not developing or maintaining an FSVP
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Incomplete or missing hazard analyses
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Lack of documentation following corrective actions
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Failure to verify that foreign suppliers meet US food safety standards
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Missing verification procedures for imported seafood
In a 2025 inspection of multiple importers (e.g., J & H Import Services Corp. and Handylee Enterprises USA Corp.), citations specifically noted the absence of developed FSVPs for products like cassava bread, liquid seasoning, and fish.
Similarly, companies like Ocean 88 Trading Corp. were cited for failing to verify sanitary conditions during fish processing, indicating a breakdown in seafood HACCP implementation.
These are not isolated cases. According to FDA enforcement data, over 70 percent of seafood-related 483s in the past two years involved inadequate hazard analysis or verification of foreign suppliers.
Most Common Observations in Jason Kwong’s Inspections
Here are the key problem areas inspectors like Jason Kwong repeatedly flag:
1. Lack of a Developed FSVP
Companies importing food must have a Foreign Supplier Verification Program. Kwong’s inspections often reveal either:
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No FSVP at all
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Poorly documented programs
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FSVPs that fail to identify hazards specific to the supplier or product
2. Inadequate Hazard Analysis
A major compliance failure is the inability to perform a proper hazard analysis:
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Biological hazards (e.g., Salmonella)
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Chemical hazards (e.g., histamine in fish)
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Physical hazards (e.g., bone fragments in seafood)
In one notable case, Fatima Brothers failed to assess hazards in uneviscerated fish, resulting in multiple citations.
3. Corrective Actions Not Documented
Even when non-compliance is identified, Kwong frequently notes that firms:
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Do not document corrective steps taken
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Do not update procedures based on previous issues
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Fail to retain relevant records
4. Missing Verification of Foreign Supplier Performance
This includes:
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No supplier evaluation
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Lack of performance tracking
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No proof of food safety compliance from the supplier
Step-by-Step Preparation Guide for QA Teams
Preparing for a Kwong-style inspection or any FDA inspection requires more than a checklist. It demands a culture of readiness supported by solid systems. Here’s how your QA team can stay prepared:
Step 1: Build and Maintain a Strong FSVP Program
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Identify every foreign supplier
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Document known or reasonably foreseeable hazards
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Ensure written procedures for evaluation and verification exist
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Keep supplier performance records updated quarterly
Step 2: Conduct Comprehensive Hazard Analyses
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Use scientific data, historical recall info, and supplier records
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Update hazard assessments at least annually or after any issue
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Include allergens, bacterial pathogens, and processing risks
Step 3: Implement a Corrective Action Record System
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Log every deviation
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Include root cause, corrective action, and follow-up
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Store records in a searchable and auditable system
Step 4: Train and Retrain
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Conduct HACCP and FSVP training at onboarding and bi-annually
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Use real inspection examples (e.g., FDA warning letters) as case studies
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Include mock audits to test comprehension
Step 5: Evaluate Your Suppliers Proactively
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Demand HACCP-compliant documentation from all suppliers
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Perform annual on-site audits or third-party evaluations
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Use tools like Atlas to access FDA inspector histories and supplier performance trends
Why Use Atlas for Inspection Readiness
Atlas is designed to help quality teams get ahead of FDA inspections by offering insights into individual inspector focus areas, historical citations, and emerging enforcement trends.
If Jason Kwong is your upcoming inspector, Atlas can help you:
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See all past inspections done by him across industries and locations
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Analyze what kinds of violations he issues most frequently
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Identify risks in your operation before the FDA does
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Generate inspector-specific readiness reports for your QA team
Using data from more than 100,000+ FDA inspection documents, Atlas acts as a predictive compliance engine. It's not just about responding to an inspector; it's about preparing with precision.
Latest Stats and Industry Context
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In 2024, the FDA issued over 2,100 483s, with seafood and foreign supplier violations making up over 30 percent
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The FSMA enforcement arm is expected to grow by 15 percent in 2025, increasing scrutiny on imported food
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Top five countries with repeat supplier violations include China, India, Vietnam, Indonesia, and Mexico
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Over 50 warning letters in 2025 already include citations for failure to verify supplier safety documentation
FAQs
Q. What is Jason Kwong’s role at the FDA?
A. Jason Kwong is an FDA investigator known for focusing on seafood HACCP regulations and FSVP compliance during site inspections.
Q. What products are most likely to be flagged under his inspections?
A. Imported foods such as fish, cassava bread, crackers, and liquid seasoning have been frequently cited during his inspections.
Q. How often should FSVP evaluations be updated?
A. FDA recommends at least once a year or whenever there’s a significant supplier change or food safety issue.
Q. What happens if I don’t have proper hazard analysis in place?
A. You risk receiving a Form 483 or even a warning letter, which can lead to product holds, recalls, or import alerts.
Q. How can Atlas help me prepare for Jason Kwong or other inspectors?
Atlas provides inspector-specific data including past 483s, focus areas, and common citations, helping you tailor your internal audits and SOPs in advance.
If you learn that Jason Kwong is your upcoming FDA inspector, it’s not a reason to panic it’s a call to prepare smarter. By focusing on known red flags like FSVP documentation and seafood HACCP compliance, and using data-driven tools like Atlas Compliance, you can turn inspections from high-stress events into confident audits.