FDA 483 OBSERVATION · #1287 OF 1,932 MOST-CITED
Monitoring--cross contamination, exposure to CD
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
Environmental conditions are not monitored when such conditions could cause contamination or cross contamination of HCT/Ps or equipment.
Environmental conditions are not monitored when such conditions could cause contamination or cross contamination of HCT/Ps or equipment.
Environmental conditions are not monitored when such conditions could cause contamination or cross contamination of HCT/Ps or equipment and the accidental exposure of HCT/Ps to communicable disease agents.
Environmental conditions are not monitored when such conditions could cause contamination or cross contamination of HCT/Ps or equipment and the accidental exposure of HCT/Ps to communicable disease agents.
Environmental conditions are not monitored when such conditions could cause contamination or cross contamination of HCT/Ps or equipment.
Environmental conditions are not monitored when such conditions could cause contamination or cross contamination of HCT/Ps or equipment.
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 →