FDA 483 OBSERVATION · #841 OF 1,000 MOST-CITED
Ensuring compliance with plan and protocol
FDA cited this observation 18 times across 17 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.
How FDA worded it — real examples
Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.
Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.
Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.
Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.
Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.
Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.
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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