FDA 483 OBSERVATION · #1204 OF 1,932 MOST-CITED
Periodic review of temperatures
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
Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.
Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.
Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.
Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.
Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.
Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →