FDA 483 OBSERVATION · #1302 OF 1,932 MOST-CITED
Causing contamination, increasing risks
FDA cited this observation 11 times across 11 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 grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
How FDA worded it — real examples
HCT/Ps were not processed in a way that does not cause contamination or cross contamination during processing and that does not increase the risk of introduction, transmission, or spread of communicable disease.
HCT/Ps were not processed in a way that does not cause contamination or cross contamination during processing.
HCT/Ps were not processed in a way that does not cause contamination or cross contamination during processing.
HCT/Ps were not processed in a way that does not cause contamination or cross contamination during processing.
HCT/Ps were not processed in a way that does not increase the risk of introduction, transmission, or spread of communicable disease.
HCT/Ps were not processed in a way that does not increase the risk of introduction, transmission, or spread of communicable disease.
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. Open the 483 observation explorer →