FDA 483 OBSERVATION · #5 OF 1,000 MOST-CITED
Lack of or inadequate complaint procedures
FDA cited this observation 1,452 times across 1,323 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 for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit 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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