FDA 483 OBSERVATION · #153 OF 1,923 MOST-CITED

Hazard analysis

FDA cited this observation 201 times across 178 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
Foods201
BY FISCAL YEAR
FY202626
FY202518
FY202414
FY202314
FY202212
FY20218
FY20208
FY201924
FY201814
FY201725
FY201638

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.4× the rate of the average FDA-cited firm (10.7% vs 7.8%), across 178 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.

CHECKING ACCESS

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How FDA worded it — real examples

You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process.

F-ONE GLOBAL FOODS COMPANY LIMITED · Dong Trieu Ward · Foods · 2026-08-18

You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process.

A.H. Hermel Candy and Tobacco · Mankato, Minnesota · Foods · 2026-07-29

You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process.

NAGASAKI TAKARA SYOKUHIN Co., Ltd. KYOUDOMARI FACTORY · Nagasaki · Foods · 2026-07-22

You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process.

Macro International LLC · Rowlett, Texas · Foods · 2026-07-09

You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process.

MARIA AQUACON PVT LTD · Kuttapuli · Foods · 2026-06-24

You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process.

Kanani Foods II, Inc. · Las Vegas, Nevada · Foods · 2026-06-12

Related SPEQ references

Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.

HACCP →Food industry →

Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →