FDA 483 OBSERVATION · #253 OF 1,923 MOST-CITED

Raw materials, packaging, finished product

FDA cited this observation 118 times across 106 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
Foods118
BY FISCAL YEAR
FY20266
FY202520
FY202412
FY20237
FY202211
FY20212
FY20206
FY20199
FY201810
FY201719
FY201616

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1× the rate of the average FDA-cited firm (7.5% vs 7.8%), across 106 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

Records are not maintained of the examination of raw materials and packaging materials to verify compliance with FDA regulations and guidelines or action levels.

Premier Distributor Of Miami, Corp. · Hialeah, Florida · Foods · 2026-06-02

Records are not maintained of the examination of raw materials, packaging materials and finished products to verify compliance with FDA regulations and guidelines or action levels.

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

Records are not maintained of the examination of finished products and supplier's guarantees or certificates to verify compliance with FDA regulations and guidelines or action levels.

Cloud Concepts LLC · Nashville, Tennessee · Foods · 2026-03-03

Records are not maintained of the examination of raw materials, packaging materials, finished products and supplier's guarantees or certificates to verify compliance with FDA regulations and guidelines or action levels.

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

Records are not maintained of the examination of raw materials, packaging materials and supplier's guarantees or certificates to verify compliance with FDA regulations and guidelines or action levels.

Space Coast Sauces · Palm Bay, Florida · Foods · 2026-01-29

Records are not maintained of the examination of raw materials and packaging materials to verify compliance with FDA regulations and guidelines or action levels.

CONFITURE PARISIENNE · Paris 12e Arrondissement · Foods · 2026-01-28

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 →

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