FDA 483 OBSERVATION · #230 OF 1,923 MOST-CITED

Specifications - contamination limits

FDA cited this observation 128 times across 118 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
Foods128
BY FISCAL YEAR
FY202425
FY202316
FY202217
FY202111
FY20208
FY201919
FY20188
FY201716
FY20168

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 5.3× the rate of the average FDA-cited firm (40.7% vs 7.8%), across 118 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 establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.

Hyalogic LLC · Riverside, Missouri · Foods · 2024-07-25

You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.

Country Life, LLC · Hauppauge, New York · Foods · 2024-07-12

You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.

Pinnacle Labs International, Inc. · Upland, California · Foods · 2024-06-14

You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.

Penn Herb Company, Ltd. · Philadelphia, Pennsylvania · Foods · 2024-06-13

You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.

Mcclarry Innovation LLC · Salt Lake City, Utah · Foods · 2024-06-07

You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.

I AM WELL HOLISTIC INC · Cleveland, Ohio · Foods · 2024-05-28

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.

Contamination control →Food industry →

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