FDA 483 OBSERVATION · #543 OF 1,000 MOST-CITED
Labeling Control Records and Label Copies
FDA cited this observation 34 times across 34 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 batch production and control records are deficient in that they do not include complete labeling control records of labeling.
The batch production and control records are deficient in that they do not include of labeling.
The batch production and control records are deficient in that they do not include complete labeling control records, specimen and copy of labeling.
The batch production and control records are deficient in that they do not include specimen of labeling.
The batch production and control records are deficient in that they do not include complete labeling control records, specimen and copy of labeling.
The batch production and control records are deficient in that they do not include specimen of labeling.
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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