FDA 483 OBSERVATION · #703 OF 1,000 MOST-CITED
Determination need for investigation
FDA cited this observation 24 times across 21 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
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not conduct an investigation and take appropriate corrective actions when necessary.
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not conduct an investigation and take appropriate corrective actions when necessary.
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not take appropriate corrective actions when necessary.
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not determine the need for an investigation, conduct an investigation and take appropriate corrective actions when necessary.
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not conduct an investigation and take appropriate corrective actions when necessary.
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not conduct an investigation and take appropriate corrective actions when necessary.
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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