FDA 483 OBSERVATION · #110 OF 1,000 MOST-CITED
Establish, maintain and follow manufacturing SOPs
FDA cited this observation 207 times across 177 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 0.1× the rate of the average FDA-cited firm (0.6% vs 8.3%), across 177 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
Written standard operating procedures including all steps to be followed in the collection of blood and blood components for allogeneic transfusion and autologous transfusion were not always established, maintained and followed.
Written standard operating procedures including all steps to be followed in the storage of blood and blood components for allogeneic transfusion were not always followed.
Written standard operating procedures including all steps to be followed in the collection of blood and blood components for allogeneic transfusion were not always followed.
Written standard operating procedures including all steps to be followed in the collection and storage of blood and blood components for were not always followed.
Written standard operating procedures including all steps to be followed in the distribution of blood and blood components for allogeneic transfusion were not always established and maintained.
Written standard operating procedures including all steps to be followed in the compatibility testing and distribution of blood and blood components for allogeneic transfusion were not always 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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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