FDA 483 OBSERVATION · #572 OF 1,932 MOST-CITED
Person performing, test results, interpretation
FDA cited this observation 43 times across 41 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.
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 0× the rate of the average FDA-cited firm (0.0% vs 7.8%), across 41 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
Records fail to identify the person performing the work so as to provide a complete history of the work performed.
Records fail to identify the person performing the work and be as detailed as necessary so as to provide a complete history of the work performed.
Records fail to identify the person performing the work so as to provide a complete history of the work performed.
Records fail to show test results so as to provide a complete history of the work performed.
Records fail to identify the person performing the work and be as detailed as necessary so as to provide a complete history of the work performed.
Records fail to identify the person performing the work, include dates of the various entries and be as detailed as necessary so as to provide a complete history of the work performed.
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 →