FDA 483 OBSERVATION · #138 OF 1,923 MOST-CITED

Corrective action per predetermined plan

FDA cited this observation 216 times across 185 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
Foods216
BY FISCAL YEAR
FY202613
FY202511
FY202418
FY202314
FY202211
FY20217
FY202021
FY201926
FY201828
FY201738
FY201629

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 (15.7% vs 7.8%), across 185 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 take corrective action that ensured affected product was not entered into commerce and the cause of the deviation was corrected.

US Foods, Inc. · Lexington, South Carolina · Foods · 2026-07-08

You did not take corrective action that ensured affected product was not entered into commerce and the cause of the deviation was corrected.

Majesty Foods LLC · Hialeah, Florida · Foods · 2026-06-17

You did not take corrective action that ensured affected product was not entered into commerce and the cause of the deviation was corrected.

Commodity Forwarders Inc. · Los Angeles, California · Foods · 2026-06-01

You did not take corrective action that ensured affected product was not entered into commerce and the cause of the deviation was corrected.

Cape May Foods LLC · Millville, New Jersey · Foods · 2026-05-28

You did not take corrective action that ensured affected product was not entered into commerce and the cause of the deviation was corrected.

Tradewind Seafood, Inc. · Oxnard, California · Foods · 2026-05-22

You did not take corrective action that ensured affected product was not entered into commerce and the cause of the deviation was corrected.

Performance Foodservice Caro Foods · Houma, Louisiana · Foods · 2026-04-13

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.

Quality risk management →Food industry →

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