FDA 483 OBSERVATION · #1291 OF 1,932 MOST-CITED
Records of continuing review
FDA cited this observation 11 times across 11 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 have not been prepared of all continuing review activities.
Records have not been prepared and maintained of all continuing review activities.
Records have not been prepared and maintained of all continuing review activities.
Records have not been prepared of all continuing review activities.
Records have not been prepared of all continuing review activities.
Records have not been prepared and maintained of all continuing review activities.
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 →