FDA 483 OBSERVATION · #966 OF 1,000 MOST-CITED
Specific information required in individual logs
FDA cited this observation 14 times across 14 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
Individual equipment logs do not show time, date, product and lot number of each batch processed.
Individual equipment logs do not show time, product and lot number of each batch processed.
Individual equipment logs do not show time, product and lot number of each batch processed.
Individual equipment logs do not show time, date, product and lot number of each batch processed.
Individual equipment logs do not show time, date, product and lot number of each batch processed.
Individual equipment logs do not show time, date, product and lot number of each batch processed.
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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