FDA 483 OBSERVATION · #784 OF 1,000 MOST-CITED
Retention time of reserve samples, in general
FDA cited this observation 20 times across 20 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 did not retain reserve samples for drug products for one year after the expiration dates of the drug products.
You did not retain reserve samples for drug products for one year after the expiration dates of the drug products.
You did not retain reserve samples for drug products for one year after the expiration dates of the drug products.
You did not retain reserve samples for drug products for one year after the expiration dates of the drug products.
You did not retain reserve samples for drug products for one year after the expiration dates of the drug products.
You did not retain reserve samples for drug products for one year after the expiration dates of the drug products.
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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