FDA 483 OBSERVATION · #802 OF 1,932 MOST-CITED
Records maintained concurrently
FDA cited this observation 24 times across 24 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
Records were not maintained concurrently with the performance of each step.
Records were not maintained concurrently with the performance of each step.
Records were not maintained concurrently with the performance of each step.
Records were not maintained concurrently with the performance of each step.
Records were not maintained concurrently with the performance of each step.
Records were not maintained concurrently with the performance of each step.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →