FDA 483 OBSERVATION · #214 OF 1,923 MOST-CITED

Sanitation Controls Procedures

FDA cited this observation 140 times across 133 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
Foods140
BY FISCAL YEAR
FY202218
FY202115
FY202030
FY201942
FY201824
FY201711

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 2× the rate of the average FDA-cited firm (15.8% vs 7.8%), across 133 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 sanitation controls procedures did not ensure cleanliness of food-contact surfaces, prevention of allergen cross-contact and prevention of cross-contamination.

McClancy Foods and Flavors LLC · Fort Mill, South Carolina · Foods · 2022-05-13

Your sanitation controls procedures did not ensure cleanliness of food-contact surfaces and prevention of allergen cross-contact.

Tropical Bakery Wholesale Corp · Hialeah, Florida · Foods · 2022-05-12

Your sanitation controls procedures did not ensure cleanliness of food-contact surfaces and prevention of cross-contamination.

Morski Brands, Inc. · Portage, Wisconsin · Foods · 2022-05-11

Your sanitation controls procedures did not ensure cleanliness of food-contact surfaces.

The Pickle Patch LLC. · Lake Wales, Florida · Foods · 2022-04-22

Your sanitation controls procedures did not ensure cleanliness of food-contact surfaces and prevention of cross-contamination.

Fruit Fresh Up, Inc. · Depew, New York · Foods · 2022-03-24

Your sanitation controls procedures did not ensure cleanliness of food-contact surfaces, prevention of allergen cross-contact and prevention of cross-contamination.

Domenico's Los Angeles, LLC · Beverly Hills, California · Foods · 2022-03-22

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.

Contamination control →Pharmaceutical quality system →Food industry →

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