FDA 483 OBSERVATION · #1238 OF 1,932 MOST-CITED
Adequate control, proper conditions
FDA cited this observation 12 times across 12 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 existed in which contamination or cross contamination of HCT/Ps or equipment could occur, and environmental conditions were not adequately controlled.
Environmental conditions existed in which contamination or cross contamination of HCT/Ps or equipment could occur, and environmental conditions were not adequately controlled.
Environmental conditions existed in which contamination or cross contamination of HCT/Ps or equipment could occur, and environmental conditions were not adequately controlled.
Environmental conditions existed in which contamination or cross contamination of HCT/Ps or equipment could occur, and environmental conditions were not adequately controlled and proper conditions for operations were not provided.
Environmental conditions existed in which contamination or cross contamination of HCT/Ps or equipment and the accidental exposure of HCT/Ps to communicable disease agents could occur, and environmental conditions were not adequately controlled.
Environmental conditions existed in which contamination or cross contamination of HCT/Ps or equipment could occur, and environmental conditions were not adequately controlled.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →