FDA 483 OBSERVATION · #855 OF 1,000 MOST-CITED
Labeling control records including specimens or copies
FDA cited this observation 22 times across 22 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
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
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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