FDA 483 OBSERVATION · #498 OF 1,000 MOST-CITED
Labeled re: biohazard, risks, test results
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 1.9× the rate of the average FDA-cited firm (15.8% 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
HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with the Biohazard legend and a statement warning of communicable disease risks.
HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with the Biohazard legend, a statement warning of communicable disease risks and a statement warning of the reactive test results.
HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with the Biohazard legend, a statement warning of communicable disease risks and a statement warning of the reactive test results.
HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with a statement warning of communicable disease risks and a statement warning of the reactive test results.
HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with the Biohazard legend and a statement warning of communicable disease risks.
HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with the Biohazard legend and a statement warning of the reactive test results.
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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