FDA 483 OBSERVATION · #863 OF 1,000 MOST-CITED
Lot or control number assigned
FDA cited this observation 17 times across 16 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 drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
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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