FDA 483 OBSERVATION · #179 OF 1,923 MOST-CITED

Identification - entry

FDA cited this observation 173 times across 160 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
Foods169
Veterinary Medicine4
BY FISCAL YEAR
FY202632
FY202558
FY202436
FY202341
FY20226

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.4× the rate of the average FDA-cited firm (10.6% vs 7.8%), across 160 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 ensure that your electronic mail address was/were provided electronically when filing entry with the U.S. Customs and Border Protection.

SUNSTAR67 · Cerritos, California · Foods · 2026-08-20

You did not ensure that the unique facility identifier recognized as acceptable by FDA was/were provided electronically when filing entry with the U.S. Customs and Border Protection.

NATURALLY PLUS USA, INC. · Las Vegas, Nevada · Foods · 2026-07-30

You did not ensure that your electronic mail address and the unique facility identifier recognized as acceptable by FDA was/were provided electronically when filing entry with the U.S. Customs and Border Protection.

FRIENDS OF SAN LUCAS · Saint Paul, Minnesota · Foods · 2026-07-17

You did not ensure that the unique facility identifier recognized as acceptable by FDA was/were provided electronically when filing entry with the U.S. Customs and Border Protection.

SW GFI, LLC · Conroe, Texas · Foods · 2026-06-22

You did not ensure that the unique facility identifier recognized as acceptable by FDA was/were provided electronically when filing entry with the U.S. Customs and Border Protection.

Halavet US LLC · Madison, Wisconsin · Foods · 2026-06-15

You did not ensure that the unique facility identifier recognized as acceptable by FDA was/were provided electronically when filing entry with the U.S. Customs and Border Protection.

Sysco Corporation · Houston, Texas · Foods · 2026-06-10

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 →Veterinary industry →

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