FDA 483 OBSERVATION · #767 OF 1,932 MOST-CITED
Record requirements
FDA cited this observation 26 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
Your required records did not include all necessary information and were not dated and signed by the person who performed the activity.
Your required records did not include all necessary information and were not dated and signed by the person who performed the activity.
Your required records did not include all necessary information.
Your required records did not include all necessary information, were not created at the time the activity was performed or observed and were not dated and signed by the person who performed the activity.
Your required records were not accurate.
Your required records did not include all necessary information and were not dated and signed by the person who performed the activity.
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 →