FDA 483 OBSERVATION · #42 OF 1,000 MOST-CITED
Case history records- inadequate or inadequate
FDA cited this observation 456 times across 446 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 prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
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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