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FDA 483 Citations
Guides to the most common FDA Form 483 inspection citations for medical device and food companies: what each citation means, what FDA expects in your response, and the procedures that fix it.


FDA 483 Citations for Food Allergen Preventive Controls Under 21 CFR 117.135
Allergen preventive control citations appeared more than 90 times on FDA 483s in fiscal year 2025. This guide explains cross-contact and labeling controls under 117.135 and how to respond.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for the Supply-Chain Program Under 21 CFR 117.405 and 117.410
Supply-chain program citations appeared 88 times on FDA 483s at food facilities in fiscal year 2025. This guide explains when Subpart G applies, what the program needs and how to respond.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for Not Having a Written Food Safety Plan Under 21 CFR 117.126
"You did not have a written food safety plan" was cited 61 times on FDA 483s in fiscal year 2025. This guide explains who needs a plan under 117.126, what it contains and how to respond.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for Food Safety Training and Qualified Individuals Under 21 CFR 117.4
Missing food hygiene training and unqualified staff were cited 61 times on FDA 483s in fiscal year 2025. This guide explains 117.4, the PCQI and how to respond.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for Warehousing and Distribution Under 21 CFR 117.93
Food storage and transportation conditions were cited 71 times on FDA 483s in fiscal year 2025. This guide explains 117.93, the link to sanitary transportation and how to respond.
Aaron Lyon
22 hours ago4 min read
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FDA 483 Citations for Sanitary Facilities Under 21 CFR 117.37
Inadequate sanitary facilities were cited 93 times on FDA 483s at food facilities in fiscal year 2025. This guide covers water, plumbing, toilets, hand washing and waste under 117.37.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for Plant and Grounds Under 21 CFR 117.20
Plant construction, design and grounds were cited more than 140 times on FDA 483s at food facilities in fiscal year 2025. This guide explains 117.20 and how to respond.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for Equipment and Utensils Under 21 CFR 117.40
Equipment and utensil design and maintenance were cited 120 times on FDA 483s at food facilities in fiscal year 2025. This guide explains 117.40 and how to respond.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for Processes and Controls Under 21 CFR 117.80
Processes and controls citations under 21 CFR 117.80 appeared more than 280 times on FDA 483s in fiscal year 2025. This guide explains the observations and how to respond.
Aaron Lyon
22 hours ago6 min read
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FDA 483 Citations for Personnel Practices Under 21 CFR 117.10
Personnel practices were cited 223 times on FDA 483s at food facilities in fiscal year 2025. This guide explains what 117.10 requires for hygiene, illness and garments, and how to respond.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for FSVP Supplier Evaluation and Verification Under 21 CFR 1.505 and 1.506
FSVP supplier evaluation and verification citations appeared more than 500 times on FDA 483s in fiscal year 2025. This guide explains evaluation, approval, verification and how to respond.
Aaron Lyon
22 hours ago6 min read
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FDA 483 Citations for FSVP Hazard Analysis Under 21 CFR 1.504
FSVP hazard analysis citations appeared 230 times on FDA 483s in fiscal year 2025. This guide explains what an importer's hazard analysis must cover and how to respond.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for Not Having an FSVP Under 21 CFR 1.502
"You did not develop an FSVP" was cited 483 times in fiscal year 2025, more than any other food observation. This guide explains who must have an FSVP, what it contains and how to respond.
Aaron Lyon
22 hours ago6 min read
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FDA 483 Citations for Juice HACCP Under 21 CFR Part 120
Juice processors drew more than 150 FDA 483 citations under the juice HACCP rule in fiscal year 2025. This guide covers sanitation, plan implementation, critical limits and the 5-log reduction.
Aaron Lyon
22 hours ago6 min read
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FDA 483 Citations for Seafood Importer Verification Under 21 CFR 123.12
Seafood importers drew 67 FDA 483 citations in fiscal year 2025 for missing verification procedures, specifications or affirmative steps. This guide explains 123.12 and how to respond.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for Implementing a Seafood HACCP Plan Under 21 CFR 123.6(b), 123.8 and 123.10
Seafood processors drew more than 150 FDA 483 citations in fiscal year 2025 for not following their own HACCP plans, skipping verification or lacking HACCP training. This guide explains each one.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for Seafood HACCP Plan Contents Under 21 CFR 123.6
Seafood HACCP plan content citations appeared more than 250 times on FDA 483s in fiscal year 2025. This guide explains what a Part 123 plan must contain and how to fix it.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for Seafood Sanitation Monitoring Under 21 CFR 123.11
Sanitation monitoring was the most cited seafood HACCP observation in fiscal year 2025, with more than 140 FDA 483 citations. This guide covers the eight key sanitation conditions and how to respond.
Aaron Lyon
22 hours ago5 min read
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FDA 483 Citations for Dietary Supplement Label and Packaging Specifications Under 21 CFR 111.70(d)
Missing label and packaging specifications drew 47 FDA 483 citations at dietary supplement firms in fiscal year 2025. This guide explains the rule and how to control labeling.
Aaron Lyon
22 hours ago4 min read
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FDA 483 Citations for Dietary Supplement Product Complaints Under 21 CFR 111.553
Missing complaint procedures drew 38 FDA 483 citations at dietary supplement firms in fiscal year 2025. This guide explains Subpart O, the link to serious adverse event reporting and how to respond.
Aaron Lyon
22 hours ago5 min read
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