FDA 483 OBSERVATION · #275 OF 1,923 MOST-CITED

Hygienic practices

FDA cited this observation 109 times across 100 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
Foods109
BY FISCAL YEAR
FY202623
FY202535
FY20246
FY202326
FY20229
FY20211
FY20203
FY20193
FY20183

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 2.3× the rate of the average FDA-cited firm (18.0% vs 7.8%), across 100 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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How FDA worded it — real examples

Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.

SUNFLOWER NUTRACEUTICALS LLC · Hialeah, Florida · Foods · 2026-08-11

You did not ensure that personnel who may contact produce or food contact surfaces use hygienic practices to protect against produce contamination.

Sinn Farms Inc · Silverton, Oregon · Foods · 2026-07-29

You did not ensure that personnel who may contact produce or food contact surfaces use hygienic practices to protect against produce contamination.

Aurora Farms LLC · Aurora, Oregon · Foods · 2026-07-27

Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.

Sentry Manufacturing, Inc. · Miami Lakes, Florida · Foods · 2026-07-21

You did not ensure that personnel who may contact produce or food contact surfaces use hygienic practices to protect against produce contamination.

Ajos La Veguilla, S.L. · Las Pedroneras · Foods · 2026-06-23

Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.

Apex Nutra LLC · Ogden, Utah · Foods · 2026-05-22

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.

Food industry →

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