FDA 483 OBSERVATION · #635 OF 1,000 MOST-CITED
Rejecting When Specifications Not Met
FDA cited this observation 35 times across 33 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 observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 6.7× the rate of the average FDA-cited firm (51.5% vs 7.7%), across 33 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
Failure to reject any lot of drug product containers that did not meet the appropriate written specifications for identity, strength, quality, and purity.
Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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