FDA 483 OBSERVATION · #790 OF 1,000 MOST-CITED
Record maintenance 1 year (except exempt OTC)
FDA cited this observation 19 times across 19 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
All records of control associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
All records of production and control associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
All records of production and control associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
All records of components associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
All records of control, distribution and labeling associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
All records of production and control associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
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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