FDA 483 OBSERVATION · #226 OF 1,923 MOST-CITED

Tests, examinations - scientifically valid

FDA cited this observation 131 times across 117 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
Foods131
BY FISCAL YEAR
FY20267
FY202519
FY202420
FY202319
FY202225
FY202117
FY20206
FY20194
FY20186
FY20173
FY20165

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 3.8× the rate of the average FDA-cited firm (29.1% vs 7.8%), across 117 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

You did not ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods.

Organic By Nature, Inc. · Rancho Dominguez, California · Foods · 2026-08-25

You did not ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods.

Country Doctor Herbals · Cheyenne, Wyoming · Foods · 2026-07-21

You did not ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods.

Neurogan, Inc. · San Diego, California · Foods · 2026-04-17

You did not ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods.

TG Labs, Inc. · Centennial, Colorado · Foods · 2026-03-19

You did not ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods.

Spartan Enterprises Inc. · Lansing, Michigan · Foods · 2026-02-18

You did not ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods.

TKS Co-pack Manufacturing, LLC · Lindon, Utah · Foods · 2026-01-27

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.

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