FDA 483 OBSERVATION · #903 OF 1,000 MOST-CITED
Documentation - review in response to changes or deviations
FDA cited this observation 16 times across 16 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
There is no documentation of the review and evaluation of a process and revalidation of a process performed in response to changes or process deviations.
There is no documentation of the revalidation of a process performed in response to changes or process deviations.
There is no documentation of the revalidation of a process performed in response to changes or process deviations.
There is no documentation of the review and evaluation of a process performed in response to changes or process deviations.
There is no documentation of the review and evaluation of a process performed in response to changes or process deviations.
There is no documentation of the review and evaluation of a process performed in response to changes or process deviations.
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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