FDA 483 OBSERVATION · #36 OF 1,923 MOST-CITED

Hazard analysis written

FDA cited this observation 601 times across 556 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.

What this grouping is not

An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.

BY PROGRAM AREA

Foods580

Veterinary Medicine21

BY FISCAL YEAR

FY202668

FY202568

FY202467

FY2023107

FY2022107

FY202181

FY202048

FY201919

FY201823

FY201713

What this observation means, and how to comply

SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.

21 CFR 117.130 (food safety plan) · seafood 21 CFR 123.6

The hazard analysis required for the food safety plan (or HACCP plan) was not written, or the written analysis was inadequate — the documented identification and evaluation of hazards was missing.

Why FDA writes it — A hazard analysis that exists only in someone’s head cannot be reviewed, verified, or relied on. The rule requires it in writing precisely so the identified hazards and the rationale for preventive controls are auditable and reproducible.

HOW TO COMPLY

Prepare a written hazard analysis identifying and evaluating the known or reasonably foreseeable hazards for each type of food.
Document which hazards require a preventive control and the reasoning for those included and excluded.
Have it prepared or overseen by a preventive-controls qualified individual (for the human-food rule).
Keep it current and reanalyze as required.

WHY FIRMS GET CITED

Hazard analysis performed informally and never documented.
A written analysis too thin to show the evaluation actually occurred.

PROFESSIONAL · REMEDIATION PLAYBOOK · SPEQ SYNTHESIS

How to close this finding — and stop it recurring

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What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.5× the rate of the average FDA-cited firm (11.5% vs 7.8%), across 556 FEI-matched firms.

This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.

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