FDA 483 OBSERVATION · #21 OF 1,923 MOST-CITED
Nonconforming product, Lack of or inadequate procedures
FDA cited this observation 838 times across 769 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.
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.
The firm lacked adequate procedures to control product that does not conform to specified requirements — to identify, document, evaluate, segregate, and disposition it, and to define who has authority to review and decide the disposition.
Why FDA writes it — Nonconforming product is where quality decisions get made under pressure. Without a controlled process, defective units get used-as-is or reworked without justification, and the same nonconformance recurs because it was never evaluated for a broader problem.
- Establish procedures to identify, document, evaluate, segregate, and disposition nonconforming product, and define the responsibility for review and the authority for disposition.
- Document the rationale for any use-as-is or accept-by-concession decision, including the evaluation that supports it.
- Control and document rework, including re-testing and re-evaluation to show the reworked product still meets requirements.
- Feed nonconformance evaluations into CAPA when they indicate a systemic cause, not just a one-off defect.
- Disposition authority undefined, so borderline product is released by whoever is under schedule pressure.
- Rework performed without re-evaluation, quietly reintroducing the same risk the nonconformance flagged.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.3× the rate of the average FDA-cited firm (10.1% vs 7.8%), across 769 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.
How FDA worded it — real examples
Procedures have not been adequately established to control product that does not conform to specified requirements.
Procedures have not been adequately established to control product that does not conform to specified requirements.
Procedures have not been adequately established to control product that does not conform to specified requirements.
Procedures have not been adequately established to control product that does not conform to specified requirements.
Procedures have not been adequately established to control product that does not conform to specified requirements.
Procedures have not been adequately established to control product that does not conform to specified requirements.
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.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →