FDA 483 OBSERVATION · #1027 OF 1,932 MOST-CITED
Storage and handling after bactericidal treatment
FDA cited this observation 17 times across 14 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
Failure to store utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse.
Failure to store utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse.
Failure to store utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse.
Failure to store utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse.
Failure to store and handle utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse.
Failure to store utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →