FDA 483 OBSERVATION · #183 OF 1,923 MOST-CITED

Sanitation Controls Verif Procedures: Establish Implement

FDA cited this observation 171 times across 156 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
Foods171
BY FISCAL YEAR
FY202219
FY202126
FY202036
FY201956
FY201827
FY20177

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 2.6× the rate of the average FDA-cited firm (19.9% vs 7.8%), across 156 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 implement adequate written sanitation controls verification procedures for environmental monitoring.

Grimmway Enterprises Inc. · Arvin, California · Foods · 2022-05-04

You did not establish and implement adequate written sanitation controls verification procedures for environmental monitoring.

The Ben Heggy Candy Co · Canton, Ohio · Foods · 2022-04-18

You did not implement adequate written sanitation controls verification procedures for environmental monitoring.

CHICAGO SWEET CONNECTION, INC. · Chicago, Illinois · Foods · 2022-03-24

You did not establish and implement adequate written sanitation controls verification procedures for environmental monitoring.

The Royal Ice Cream Company Inc. · Manchester, Connecticut · Foods · 2022-02-22

You did not implement adequate written sanitation controls verification procedures for product testing and environmental monitoring.

Sirob Imports, Inc. · Lindenhurst, New York · Foods · 2022-02-09

You did not establish and implement adequate written sanitation controls verification procedures for product testing and environmental monitoring.

Atlantic Bakery Ltd. · Delray Beach, Florida · Foods · 2022-01-27

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.

Contamination control →Pharmaceutical quality system →Food industry →

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