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.
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 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.
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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