FDA 483 OBSERVATION · #261 OF 1,923 MOST-CITED

Recall procedures

FDA cited this observation 114 times across 103 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
Foods112
Veterinary Medicine2
BY FISCAL YEAR
FY20264
FY202512
FY20249
FY20236
FY20228
FY20212
FY20204
FY201912
FY201811
FY201730
FY201616

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 0.6× the rate of the average FDA-cited firm (4.9% vs 7.8%), across 103 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 prepare and maintain files on current procedures for recalling products that may be injurious to health, identifying, collecting, warehousing, and controlling products and implementing recall programs.

Arizona Spice Company, LLC · Mesa, Arizona · Foods · 2026-06-08

You did not prepare and maintain files on current procedures for recalling products which may be injurious to health, determining effectiveness of recalls, notifying FDA of recalls and implementing recall programs.

Pujado Solano S.A. · Santona · Foods · 2026-04-07

You did not prepare and maintain files on current procedures for recalling products that may be injurious to health and notifying FDA of recalls.

Stuart's Cajun Pickles II. LLC · Pascagoula, Mississippi · Foods · 2026-03-16

You did not prepare and maintain files on current procedures for recalling products that may be injurious to health, identifying, collecting, warehousing, and controlling products, determining the effectiveness of recalls, notifying FDA of recalls and implementing recall programs.

Uncle Edik's Pickles LLC · Fresh Meadows, New York · Foods · 2026-02-26

You did not prepare and maintain files on current procedures for recalling products that may be injurious to health, identifying, collecting, warehousing, and controlling products, determining the effectiveness of recalls, notifying FDA of recalls and implementing recall programs.

Christopher Dale Butler · El Dorado, Arkansas · Foods · 2025-09-23

You did not prepare and maintain files on current procedures for recalling products that may be injurious to health, identifying, collecting, warehousing, and controlling products, determining the effectiveness of recalls, notifying FDA of recalls and implementing recall programs.

The Pickle Patch LLC. · Lake Wales, Florida · Foods · 2025-09-15

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.

Pharmaceutical quality system →Food industry →Veterinary industry →

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