FDA 483 OBSERVATION · #239 OF 1,923 MOST-CITED
Procedures to be written and followed
FDA cited this observation 125 times across 120 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 5.7× the rate of the average FDA-cited firm (44.2% vs 7.8%), across 120 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
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Procedures describing the handling of all written and oral complaints regarding a drug product are not established.
Procedures describing the handling of all written and oral complaints regarding a drug product are not established and followed.
Procedures describing the handling of all written and oral complaints regarding a drug product are not established, written and followed.
Procedures describing the handling of all written and oral complaints regarding a drug product are not established, written and followed.
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 →