FDA 483 OBSERVATION · #844 OF 1,000 MOST-CITED
Procedure for nonconforming product not documented
FDA cited this observation 18 times across 18 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 to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation, and disposition of nonconforming product were not documented.
Procedures to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation, and disposition of nonconforming product were not documented.
Procedures to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation, and disposition of nonconforming product were not documented.
Procedures to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation, and disposition of nonconforming product were not adequately documented.
Procedures to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation, and disposition of nonconforming product were not adequately documented.
Procedures to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation, and disposition of nonconforming product were not adequately documented.
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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