FDA 483 OBSERVATION · #336 OF 1,000 MOST-CITED
Procedures for product review,disposition lack of/inadequate
FDA cited this observation 62 times across 62 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
Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been adequately established.
Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been adequately established.
Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been adequately established.
Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been adequately established.
Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been established.
Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been adequately established.
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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