FDA 483 Citations for FSVP Hazard Analysis Under 21 CFR 1.504

22 hours ago

5 min read

The hazard analysis is the starting point of every Foreign Supplier Verification Program. In fiscal year 2025, FDA investigators recorded these observations about it on system-generated Form FDA 483s:

"Your hazard analysis did not identify a hazard that requires a control," 1.504(b)(1), 89 times
Did not document the review and assessment of a hazard analysis conducted by another entity, 1.504(d), 72 times
"You did not have a written hazard analysis," 1.504(a), 69 times

That is 230 citations. A weak hazard analysis makes every later step weak too. If the importer does not know which hazards matter for a food, it cannot evaluate the supplier's controls or choose the right verification.

What the citations mean

Examples written after "Specifically" usually describe:

No written hazard analysis for some or all imported foods
A hazard analysis that lists only general hazards, without considering the specific food and process
Known hazards left out, such as Salmonella in nuts, seeds and spices, Listeria in ready-to-eat cheese, aflatoxins in peanuts, heavy metals in rice, pesticide residues, or undeclared allergens
Relying on the foreign supplier's hazard analysis without reviewing it
A supplier's hazard analysis on file, but in a foreign language or for a different product
Hazards identified but not evaluated for severity and probability

What 21 CFR 1.504 requires

Written hazard analysis (1.504(a)). You must identify and evaluate, based on experience, illness data, scientific reports and other information, known or reasonably foreseeable hazards for each type of food you import, to determine whether there are any hazards requiring a control. Your hazard analysis must be written regardless of its outcome.

Hazard identification (1.504(b)). The analysis must consider known or reasonably foreseeable hazards that are:

Biological, including microbiological hazards such as parasites, environmental pathogens and other pathogens
Chemical, including radiological hazards, pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens
Physical, such as stones, glass and metal fragments

It must also consider hazards that may be present in the food because they occur naturally, may be unintentionally introduced, or may be intentionally introduced for purposes of economic gain.

Hazard evaluation (1.504(c)). The evaluation must assess the probability that the hazard will occur in the absence of controls and the severity of the illness or injury if it does. It must consider factors such as the formulation of the food, the condition, function and design of the establishment and equipment, raw materials and ingredients, transportation practices, harvesting, raising, manufacturing, processing and packing procedures, packaging and labeling activities, storage and distribution, intended or reasonably foreseeable use, sanitation and any other relevant factors.

Review of another entity's hazard analysis (1.504(d)). If another entity, such as your foreign supplier, has analyzed the hazards for the food, you may meet these requirements by reviewing and assessing that analysis. You must document the review and assessment, including documenting that the hazard analysis was conducted by a qualified individual.

Hazards controlled by others (1.504(e)). You do not need to address hazards that the food cannot practically be consumed without being controlled, such as coffee beans that are roasted before use, or hazards that will be controlled under 1.507 by you or your customer, provided the required disclosures and written assurances are in place.

How to respond to the 483

FDA does not set a single deadline for responding to a food 483, but most firms respond in writing within 15 business days, so FDA has the response before it decides on further action.

Write a hazard analysis for each food

Have the qualified individual write a hazard analysis for each type of food. Use sources such as FDA guidance, outbreak and recall history for the food, the FDA hazards guide for the preventive controls rule, import alerts and published research. For each potential hazard, record whether it requires a control and why.

Review supplier analyses properly

Where you rely on a foreign supplier's hazard analysis, obtain it in English or translate it, confirm it covers the same food and process, check that a qualified individual prepared it, and document your assessment and any gaps.

Connect the analysis to supplier evaluation

For each hazard requiring a control, identify who controls it: the foreign supplier, its raw material supplier, you or your customer. This drives the supplier evaluation and choice of verification activities under 1.505 and 1.506.

Reassess

Update the hazard analysis when you learn of new hazards, such as a recall or import alert for the same food, and at the 3-year FSVP reevaluation.

What a compliant FSVP hazard analysis contains

Food description, ingredients, process and intended use
Biological, chemical and physical hazards considered
Economically motivated adulteration considered
Probability and severity evaluation for each hazard
Conclusion on hazards requiring a control
Who controls each hazard
Sources used
Review and assessment of any supplier analysis
Name and qualifications of the qualified individual
Date and signature

Common mistakes in FSVP hazard analysis responses

Using one generic analysis for very different foods
Leaving out allergens, pesticides or economically motivated adulteration
Filing the supplier's analysis without a documented review
Concluding "no hazards" without a rationale
Writing the analysis once and never updating it

Example: how one response section might read

This illustrates structure only; your response must describe your own foods and facts.

Observation 2: Your hazard analysis did not identify a hazard that requires a control. Specifically, the hazard analysis for ground cumin does not identify Salmonella.

Response:

Correction: The qualified individual revised the hazard analysis on a stated date. It identifies Salmonella as a hazard requiring a control, based on FDA's spice risk profile and recall history, and lead as a chemical hazard requiring evaluation.
Supplier evaluation: The supplier's steam treatment was evaluated, and its validation study and treatment records were reviewed.
Verification: Lot treatment records will be reviewed for each shipment, and one shipment per quarter will be tested for Salmonella.
Extended review: Hazard analyses for all 22 imported foods were reviewed against FDA guidance. Six were revised by a stated date.

Frequently asked questions

Can we use our supplier's hazard analysis?

Yes. You may review and assess another entity's hazard analysis, but you must document the review and assessment and that a qualified individual conducted the analysis.

Do we need a written analysis if no hazards require a control?

Yes. Section 1.504(a) requires a written hazard analysis regardless of its outcome.

Does economically motivated adulteration count?

Yes. The analysis must consider hazards that may be intentionally introduced for economic gain, such as melamine in protein ingredients or lead chromate in spices.

How A.P. Lyon documents help

A.P. Lyon's Hazard Analysis Procedure and Preliminary Steps for Hazard Analysis Procedure cover hazard identification and evaluation. The Food Fraud Vulnerability Assessment Procedure covers economically motivated adulteration, and the Food Safety Plan and HACCP Workbook provides worksheets. A.P. Lyon does not sell a stand-alone FSVP program.

Documents are editable Word and Excel files and must be adapted to your foods and suppliers. A qualified individual must perform or review your hazard analysis. A.P. Lyon does not provide food safety consulting.

Next steps

Write a hazard analysis for each imported food
Document your review of any supplier hazard analysis
Identify who controls each hazard requiring a control
Respond in writing within 15 business days with dates for each action

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