FDA 483 OBSERVATION · #744 OF 1,000 MOST-CITED
Records, DHR {see also 820.184(e)}
FDA cited this observation 21 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
Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.
Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.
Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.
Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.
Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.
Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.
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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