FDA 483 OBSERVATION · #321 OF 1,000 MOST-CITED
Expired drugs administered
FDA cited this observation 66 times across 64 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
You administered an expired drug to a food-producing animal.
Expired drug(s) were observed in the drug storage area.
Expired drug(s) were observed in the drug storage area.
Expired drug(s) were observed in the drug storage area.
Expired drug(s) were observed in the drug storage area.
Expired drug(s) were observed in the drug storage area.
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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