FDA 483 OBSERVATION · #105 OF 1,923 MOST-CITED

Complaints

FDA cited this observation 284 times across 267 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

Devices284

BY FISCAL YEAR

FY20264

FY202530

FY202435

FY202320

FY202219

FY20217

FY202020

FY201930

FY201833

FY201746

FY201640

What this observation means, and how to comply

SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.

21 CFR 111.560 (dietary supplements)

A dietary-supplement manufacturer did not adequately review and investigate product complaints — the reports from consumers or others that may indicate the product does not meet its specifications or is otherwise associated with a problem.

Why FDA writes it — Complaints are the manufacturer’s early-warning signal for product problems in the field. Failing to review and investigate them means real defects and safety signals go undetected and uncorrected, so the same problem recurs and reaches more consumers.

HOW TO COMPLY

Establish and follow procedures for the review and investigation of product complaints.
Have a qualified person review each complaint to determine whether it involves a possible failure to meet specifications or other CGMP requirements.
Investigate complaints that involve a possible failure, and extend the investigation where warranted.
Document the complaint, review, investigation, and any corrective action.

WHY FIRMS GET CITED

Complaints handled ad hoc, so signals and trends are missed.
No investigation of complaints that indicate a possible specification failure.

PROFESSIONAL · REMEDIATION PLAYBOOK · SPEQ SYNTHESIS

How to close this finding — and stop it recurring

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What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 0.9× the rate of the average FDA-cited firm (6.7% vs 7.8%), across 267 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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