FDA 483 OBSERVATION · #718 OF 1,000 MOST-CITED
DHR documentation of label release {see also 820.184}
FDA cited this observation 28 times across 28 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
The DHR does not include records of examination and release of device labeling, including date and signature of the examiner.
The DHR does not include records of examination and release of device labeling, including date and signature of the examiner.
The DHR does not include records of examination and release of device labeling, including date and signature of the examiner.
The DHR does not include records of examination and release of device labeling, including date and signature of the examiner.
The DHR does not include records of examination and release of device labeling, including date and signature of the examiner.
The DHR does not include records of examination and release of device labeling, including date and signature of the examiner.
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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