FDA 483 OBSERVATION · #878 OF 1,000 MOST-CITED
Complaints reviewed by Quality Control Unit
FDA cited this observation 16 times across 16 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
Written procedures describing the handling of complaints do not include provisions for a determination as to the need for an investigation of any unexplained discrepancy.
Written procedures describing the handling of complaints do not include provisions for explaining the reasons for the failure of the batch or any of its components to meet specifications.
Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications.
Written procedures describing the handling of complaints do not include provisions for a determination as to the need for an investigation of any unexplained discrepancy.
Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications, a determination as to the need for an investigation of any unexplained discrepancy and explaining the reasons for the failure of the batch or any of its components to meet specifications.
Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and a determination as to the need for an investigation of any unexplained discrepancy.
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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