FDA 483 OBSERVATION · #251 OF 1,923 MOST-CITED

Raw materials - Allergen identification

FDA cited this observation 119 times across 112 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
Foods119
BY FISCAL YEAR
FY202613
FY202512
FY20248
FY202313
FY202211
FY20217
FY202012
FY201924
FY201815
FY20174

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 0.9× the rate of the average FDA-cited firm (7.1% vs 7.8%), across 112 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 hold raw materials and other ingredients that are food allergens, and rework that contains food allergens, in a manner that protects against allergen cross-contact.

Pollen Collection & Sales, Inc. dba Pollen Ranch · Visalia, California · Foods · 2026-07-15

You did not identify raw materials and other ingredients that are food allergens, and rework that contains food allergens, in a manner that protects against allergen cross-contact.

Violet Sanford Holdings, LLC · Sanford, North Carolina · Foods · 2026-07-15

You did not hold raw materials and other ingredients that are food allergens, and rework that contains food allergens, in a manner that protects against allergen cross-contact.

Cookie Enterprises Inc. · Brooklyn, New York · Foods · 2026-07-07

You did not identify raw materials and other ingredients that are food allergens, and rework that contains food allergens, in a manner that protects against allergen cross-contact.

Rubicon Bakers, LLC · Richmond, California · Foods · 2026-07-06

You did not hold raw materials and other ingredients that are food allergens, and rework that contains food allergens, in a manner that protects against allergen cross-contact.

Golden State Foods Corporation · Conyers, Georgia · Foods · 2026-06-18

You did not hold raw materials and other ingredients that are food allergens, and rework that contains food allergens, in a manner that protects against allergen cross-contact.

Tsuo, Inc. dba Canaan Foods · Irwindale, California · Foods · 2026-06-09

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 →