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<title>Breaking Local News &#45; Shalu Shrotiya</title>
<link>https://www.bipphoenix.com/rss/author/shalu-shrotiya</link>
<description>Breaking Local News &#45; Shalu Shrotiya</description>
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<dc:rights>Copyright 2025 BIP Phoenix &#45; All Rights Reserved.</dc:rights>

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<title>If Jason Kwong Is Your FDA Inspector Here’s How to Stay Ready</title>
<link>https://www.bipphoenix.com/jason-kwong-fda-inspection-readiness</link>
<guid>https://www.bipphoenix.com/jason-kwong-fda-inspection-readiness</guid>
<description><![CDATA[ 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. ]]></description>
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<pubDate>Wed, 09 Jul 2025 17:31:17 +0600</pubDate>
<dc:creator>Shalu Shrotiya</dc:creator>
<media:keywords>Jason Kwong FDA inspection</media:keywords>
<content:encoded><![CDATA[<p data-start="76" data-end="470">When the FDA comes knocking, every detail matters especially if the inspector is<strong data-start="176" data-end="191">Jason Kwong</strong>. Known for his thorough assessments under the <strong data-start="238" data-end="286">Foreign Supplier Verification Program (FSVP)</strong> and <strong data-start="291" data-end="349">Seafood Hazard Analysis Critical Control Point (HACCP)</strong> regulations, Kwong's inspection history reveals patterns that food importers and processors cannot afford to overlook.</p>
<p data-start="472" data-end="757">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. Well also show how using a tool like <strong data-start="695" data-end="704">Atlas</strong> can give your compliance efforts a competitive edge.</p>
<h2 data-start="764" data-end="813">Understanding Jason Kwongs Inspection Focus</h2>
<p data-start="815" data-end="891">Inspector Jason Kwongs reports frequently center around two critical areas:</p>
<ol data-start="893" data-end="953">
<li data-start="893" data-end="917">
<p data-start="896" data-end="917"><strong data-start="896" data-end="915">FSVP Violations</strong></p>
</li>
<li data-start="918" data-end="953">
<p data-start="921" data-end="953"><strong data-start="921" data-end="953">Seafood HACCP Non-Compliance</strong></p>
</li>
</ol>
<p data-start="955" data-end="1060">Based on publicly available <strong data-start="983" data-end="1015">FDA 483s and warning letters</strong>, Kwong has consistently cited companies for:</p>
<ul data-start="1062" data-end="1322">
<li data-start="1062" data-end="1101">
<p data-start="1064" data-end="1101">Not developing or maintaining an FSVP</p>
</li>
<li data-start="1102" data-end="1141">
<p data-start="1104" data-end="1141">Incomplete or missing hazard analyses</p>
</li>
<li data-start="1142" data-end="1194">
<p data-start="1144" data-end="1194">Lack of documentation following corrective actions</p>
</li>
<li data-start="1195" data-end="1267">
<p data-start="1197" data-end="1267">Failure to verify that foreign suppliers meet US food safety standards</p>
</li>
<li data-start="1268" data-end="1322">
<p data-start="1270" data-end="1322">Missing verification procedures for imported seafood</p>
</li>
</ul>
<p data-start="1324" data-end="1763">In a 2025 inspection of multiple importers (e.g., <strong data-start="1374" data-end="1405">J &amp; H Import Services Corp.</strong> and <strong data-start="1410" data-end="1444">Handylee Enterprises USA Corp.</strong>), citations specifically noted <strong data-start="1476" data-end="1570">the absence of developed FSVPs for products like cassava bread, liquid seasoning, and fish</strong>.<br data-start="1571" data-end="1574">Similarly, companies like <strong data-start="1600" data-end="1626">Ocean 88 Trading Corp.</strong> were cited for <strong data-start="1642" data-end="1683">failing to verify sanitary conditions</strong> during fish processing, indicating a breakdown in seafood HACCP implementation.</p>
<p data-start="1765" data-end="1969">These are not isolated cases. <strong data-start="1795" data-end="1969">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.</strong></p>
<h2 data-start="1976" data-end="2034">Most Common Observations in Jason Kwongs Inspections</h2>
<p data-start="2036" data-end="2111">Here are the key problem areas inspectors like Jason Kwong repeatedly flag:</p>
<h3 data-start="2113" data-end="2148">1. <strong data-start="2120" data-end="2148">Lack of a Developed FSVP</strong></h3>
<p data-start="2149" data-end="2265">Companies importing food must have a Foreign Supplier Verification Program. Kwongs inspections often reveal either:</p>
<ul data-start="2266" data-end="2385">
<li data-start="2266" data-end="2282">
<p data-start="2268" data-end="2282">No FSVP at all</p>
</li>
<li data-start="2283" data-end="2311">
<p data-start="2285" data-end="2311">Poorly documented programs</p>
</li>
<li data-start="2312" data-end="2385">
<p data-start="2314" data-end="2385">FSVPs that fail to identify hazards specific to the supplier or product</p>
</li>
</ul>
<h3 data-start="2387" data-end="2424">2. <strong data-start="2394" data-end="2424">Inadequate Hazard Analysis</strong></h3>
<p data-start="2425" data-end="2505">A major compliance failure is the inability to perform a proper hazard analysis:</p>
<ul data-start="2506" data-end="2643">
<li data-start="2506" data-end="2545">
<p data-start="2508" data-end="2545">Biological hazards (e.g., Salmonella)</p>
</li>
<li data-start="2546" data-end="2590">
<p data-start="2548" data-end="2590">Chemical hazards (e.g., histamine in fish)</p>
</li>
<li data-start="2591" data-end="2643">
<p data-start="2593" data-end="2643">Physical hazards (e.g., bone fragments in seafood)</p>
</li>
</ul>
<p data-start="2645" data-end="2766">In one notable case, <strong data-start="2666" data-end="2685">Fatima Brothers</strong> failed to assess hazards in uneviscerated fish, resulting in multiple citations.</p>
<h3 data-start="2768" data-end="2812">3. <strong data-start="2775" data-end="2812">Corrective Actions Not Documented</strong></h3>
<p data-start="2813" data-end="2887">Even when non-compliance is identified, Kwong frequently notes that firms:</p>
<ul data-start="2888" data-end="3014">
<li data-start="2888" data-end="2928">
<p data-start="2890" data-end="2928">Do not document corrective steps taken</p>
</li>
<li data-start="2929" data-end="2980">
<p data-start="2931" data-end="2980">Do not update procedures based on previous issues</p>
</li>
<li data-start="2981" data-end="3014">
<p data-start="2983" data-end="3014">Fail to retain relevant records</p>
</li>
</ul>
<h3 data-start="3016" data-end="3079">4. <strong data-start="3023" data-end="3079">Missing Verification of Foreign Supplier Performance</strong></h3>
<p data-start="3080" data-end="3094">This includes:</p>
<ul data-start="3095" data-end="3205">
<li data-start="3095" data-end="3119">
<p data-start="3097" data-end="3119">No supplier evaluation</p>
</li>
<li data-start="3120" data-end="3150">
<p data-start="3122" data-end="3150">Lack of performance tracking</p>
</li>
<li data-start="3151" data-end="3205">
<p data-start="3153" data-end="3205">No proof of food safety compliance from the supplier</p>
</li>
</ul>
<h2 data-start="3212" data-end="3260">Step-by-Step Preparation Guide for QA Teams</h2>
<p data-start="3262" data-end="3459">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. Heres how your QA team can stay prepared:</p>
<h3 data-start="3461" data-end="3515">Step 1: Build and Maintain a Strong FSVP Program</h3>
<ul data-start="3516" data-end="3726">
<li data-start="3516" data-end="3551">
<p data-start="3518" data-end="3551">Identify every foreign supplier</p>
</li>
<li data-start="3552" data-end="3604">
<p data-start="3554" data-end="3604">Document known or reasonably foreseeable hazards</p>
</li>
<li data-start="3605" data-end="3672">
<p data-start="3607" data-end="3672">Ensure written procedures for evaluation and verification exist</p>
</li>
<li data-start="3673" data-end="3726">
<p data-start="3675" data-end="3726">Keep supplier performance records updated quarterly</p>
</li>
</ul>
<h3 data-start="3728" data-end="3779">Step 2: Conduct Comprehensive Hazard Analyses</h3>
<ul data-start="3780" data-end="3979">
<li data-start="3780" data-end="3849">
<p data-start="3782" data-end="3849">Use scientific data, historical recall info, and supplier records</p>
</li>
<li data-start="3850" data-end="3916">
<p data-start="3852" data-end="3916">Update hazard assessments at least annually or after any issue</p>
</li>
<li data-start="3917" data-end="3979">
<p data-start="3919" data-end="3979">Include allergens, bacterial pathogens, and processing risks</p>
</li>
</ul>
<h3 data-start="3981" data-end="4038">Step 3: Implement a Corrective Action Record System</h3>
<ul data-start="4039" data-end="4174">
<li data-start="4039" data-end="4062">
<p data-start="4041" data-end="4062">Log every deviation</p>
</li>
<li data-start="4063" data-end="4119">
<p data-start="4065" data-end="4119">Include root cause, corrective action, and follow-up</p>
</li>
<li data-start="4120" data-end="4174">
<p data-start="4122" data-end="4174">Store records in a searchable and auditable system</p>
</li>
</ul>
<h3 data-start="4176" data-end="4207">Step 4: Train and Retrain</h3>
<ul data-start="4208" data-end="4394">
<li data-start="4208" data-end="4273">
<p data-start="4210" data-end="4273">Conduct HACCP and FSVP training at onboarding and bi-annually</p>
</li>
<li data-start="4274" data-end="4350">
<p data-start="4276" data-end="4350">Use real inspection examples (e.g., FDA warning letters) as case studies</p>
</li>
<li data-start="4351" data-end="4394">
<p data-start="4353" data-end="4394">Include mock audits to test comprehension</p>
</li>
</ul>
<h3 data-start="4396" data-end="4445">Step 5: Evaluate Your Suppliers Proactively</h3>
<ul data-start="4446" data-end="4661">
<li data-start="4446" data-end="4505">
<p data-start="4448" data-end="4505">Demand HACCP-compliant documentation from all suppliers</p>
</li>
<li data-start="4506" data-end="4566">
<p data-start="4508" data-end="4566">Perform annual on-site audits or third-party evaluations</p>
</li>
<li data-start="4567" data-end="4661">
<p data-start="4569" data-end="4661">Use tools like <strong data-start="4584" data-end="4593">Atlas</strong> to access FDA inspector histories and supplier performance trends</p>
</li>
</ul>
<h2 data-start="4668" data-end="4711">Why Use Atlas for Inspection Readiness</h2>
<p data-start="4713" data-end="4900"><strong data-start="4713" data-end="4722">Atlas</strong> 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.</p>
<p data-start="4902" data-end="4964">If Jason Kwong is your upcoming inspector, Atlas can help you:</p>
<ul data-start="4966" data-end="5223">
<li data-start="4966" data-end="5038">
<p data-start="4968" data-end="5038">See all past inspections done by him across industries and locations</p>
</li>
<li data-start="5039" data-end="5101">
<p data-start="5041" data-end="5101">Analyze what kinds of violations he issues most frequently</p>
</li>
<li data-start="5102" data-end="5158">
<p data-start="5104" data-end="5158">Identify risks in your operation before the FDA does</p>
</li>
<li data-start="5159" data-end="5223">
<p data-start="5161" data-end="5223">Generate inspector-specific readiness reports for your QA team</p>
</li>
</ul>
<p data-start="5225" data-end="5420">Using data from more than <strong data-start="5251" data-end="5288">100,000+ FDA inspection documents</strong>, Atlas acts as a predictive compliance engine. It's not just about responding to an inspector; it's about preparing with precision.</p>
<h2 data-start="5427" data-end="5465">Latest Stats and Industry Context</h2>
<ul data-start="5467" data-end="5927">
<li data-start="5467" data-end="5586">
<p data-start="5469" data-end="5586"><strong data-start="5469" data-end="5512">In 2024, the FDA issued over 2,100 483s</strong>, with seafood and foreign supplier violations making up over 30 percent</p>
</li>
<li data-start="5587" data-end="5699">
<p data-start="5589" data-end="5699">The <strong data-start="5593" data-end="5613">FSMA enforcement</strong> arm is expected to grow by 15 percent in 2025, increasing scrutiny on imported food</p>
</li>
<li data-start="5700" data-end="5811">
<p data-start="5702" data-end="5811"><strong data-start="5702" data-end="5756">Top five countries with repeat supplier violations</strong> include China, India, Vietnam, Indonesia, and Mexico</p>
</li>
<li data-start="5812" data-end="5927">
<p data-start="5814" data-end="5927"><strong data-start="5814" data-end="5849">Over 50 warning letters in 2025</strong> already include citations for failure to verify supplier safety documentation</p>
</li>
</ul>
<h2 data-start="5934" data-end="5943">FAQs</h2>
<h3 data-start="5945" data-end="5989">Q. What is Jason Kwongs role at the FDA?</h3>
<p data-start="5990" data-end="6117">A. Jason Kwong is an FDA investigator known for focusing on seafood HACCP regulations and FSVP compliance during site inspections.</p>
<h3 data-start="6119" data-end="6191">Q. What products are most likely to be flagged under his inspections?</h3>
<p data-start="6192" data-end="6317">A. Imported foods such as fish, cassava bread, crackers, and liquid seasoning have been frequently cited during his inspections.</p>
<h3 data-start="6319" data-end="6370">Q. How often should FSVP evaluations be updated?</h3>
<p data-start="6371" data-end="6478">A. FDA recommends at least once a year or whenever theres a significant supplier change or food safety issue.</p>
<h3 data-start="6480" data-end="6547">Q. What happens if I dont have proper hazard analysis in place?</h3>
<p data-start="6548" data-end="6663">A. You risk receiving a Form 483 or even a warning letter, which can lead to product holds, recalls, or import alerts.</p>
<h3 data-start="6665" data-end="6737">Q. How can Atlas help me prepare for Jason Kwong or other inspectors?</h3>
<p data-start="6738" data-end="6893">Atlas provides inspector-specific data including past 483s, focus areas, and common citations, helping you tailor your internal audits and SOPs in advance.</p>
<p data-start="6738" data-end="6893">If you learn that Jason Kwong is your upcoming FDA inspector, its not a reason to panic its a call to prepare smarter. By focusing on known red flags like FSVP documentation and seafood HACCP compliance, and using data-driven tools like <a href="https://atlas-compliance.ai/" target="_blank" rel="noopener nofollow">Atlas Compliance</a>, you can turn inspections from high-stress events into confident audits.</p>]]> </content:encoded>
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