FDA 483 OBSERVATION · #427 OF 1,000 MOST-CITED
Results not used for expiration dates, storage cond.
FDA cited this observation 45 times across 43 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
Results of stability testing are not used in determining expiration dates.
Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
Results of stability testing are not used in determining expiration dates.
Results of stability testing are not used in determining appropriate storage conditions and expiration dates. Electronic records are used, but they do not meet audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
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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