FDA 483 OBSERVATION · #315 OF 1,000 MOST-CITED
Production and Process Change Procedures, lack of or Inad.
FDA cited this observation 90 times across 88 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 observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.6× the rate of the average FDA-cited firm (12.5% vs 7.7%), across 88 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 for changes to a process and procedure have not been adequately established.
Procedures for changes to a specification have not been adequately established.
Procedures for changes to a process and procedure have not been adequately established.
Procedures for changes to a process have not been adequately established.
Procedures for changes to a process have not been established.
Procedures for changes to a specification and process have not been adequately established.
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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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