FDA 483 OBSERVATION · #504 OF 1,000 MOST-CITED
Hold - mix-up, contamination, deterioration
FDA cited this observation 38 times across 31 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 3.1× the rate of the average FDA-cited firm (25.8% vs 8.3%), across 31 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
You held components under conditions that lead to mix-up, contamination, or deterioration.
You held components and dietary supplements under conditions that lead to mix-up, contamination, or deterioration.
You held dietary supplements under conditions that lead to mix-up, contamination, or deterioration.
You held dietary supplements under conditions that lead to mix-up, contamination, or deterioration.
You held dietary supplements under conditions that lead to mix-up, contamination, or deterioration.
You held components, dietary supplements and labels under conditions that lead to mix-up, contamination, or deterioration.
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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