FDA 483 OBSERVATION · #634 OF 1,000 MOST-CITED
Records - available; FDA
FDA cited this observation 27 times across 27 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
You did not have required records, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested.
You did not have required records, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested.
You did not have required records, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested.
You did not have required records, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested.
You did not have required records, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested.
You did not have required records, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested.
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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