FDA 483 OBSERVATION · #503 OF 1,000 MOST-CITED
Hazardous drugs, prevention of cross-contamination
FDA cited this observation 38 times across 38 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 5× the rate of the average FDA-cited firm (42.1% vs 8.3%), across 38 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 produced hazardous drugs without providing adequate cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
You produced hazardous drugs without providing adequate segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
You produced hazardous drugs without providing adequate segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
You produced hazardous drugs without providing adequate cleaning of work surfaces to prevent cross-contamination.
You produced hazardous drugs without providing adequate cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
You produced hazardous drugs without providing adequate cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
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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