FDA 483 OBSERVATION · #274 OF 1,923 MOST-CITED

Written procedures - product complaint; review, investigate

FDA cited this observation 108 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
Foods108
BY FISCAL YEAR
FY20247
FY20238
FY202210
FY20212
FY20205
FY20197
FY201819
FY201727
FY201623

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 4.6× the rate of the average FDA-cited firm (35.9% 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 make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint.

Wholly Liquid Nutritional Supplements LLC · Hampton, New Hampshire · Foods · 2024-06-27

You did not make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint.

Inca Living Corp · Boca Raton, Florida · Foods · 2024-06-24

You did not make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint.

Nutra Group LLC · Lake Ronkonkoma, New York · Foods · 2024-06-10

You did not make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint.

Source-Omega LLC · South Lebanon, Ohio · Foods · 2024-02-28

You did not make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint.

Talisman LLC dba American Metabolix · Richardson, Texas · Foods · 2024-01-31

You did not make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint.

Natural Ginger, Corp · Medley, Florida · Foods · 2023-12-22

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 →Pharmaceutical quality system →Food industry →

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