FDA 483 OBSERVATION · #47 OF 1,923 MOST-CITED

Quality audits - Lack of or inadequate procedures

FDA cited this observation 515 times across 473 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

Devices515

BY FISCAL YEAR

FY202614

FY202550

FY202441

FY202335

FY202248

FY202113

FY202036

FY201977

FY201869

FY201764

FY201668

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 820.22

A device firm lacked adequate procedures for quality audits, or did not conduct them — the internal audits that check whether the quality system is working and conforms to requirements, with re-audit of deficient matters.

Why FDA writes it — Quality audits are how a firm finds its own problems before FDA does. Without them, the quality system has no internal feedback loop, deficiencies persist unseen, and the firm cannot demonstrate it monitors its own compliance — so the missing audit program is itself a system-level finding.

HOW TO COMPLY

Establish procedures for quality audits and conduct them to assure the quality system is in compliance and to determine its effectiveness.
Ensure audits are conducted by individuals who do not have direct responsibility for the matters being audited.
Document each audit and any re-audits, and take corrective action where deficiencies are found.
Make audit results available to management with executive responsibility, but keep audit reports appropriately confidential per the regulation.

WHY FIRMS GET CITED

Auditors assigned to areas they are responsible for, compromising independence.
Audits performed but findings not driven to corrective action and re-audit, so the loop never closes.

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 1.5× the rate of the average FDA-cited firm (11.8% vs 7.8%), across 473 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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