FDA 483 OBSERVATION · #289 OF 1,000 MOST-CITED
Design review - Lack of or inadequate procedures
FDA cited this observation 75 times across 74 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 design review have not been adequately established.
Procedures for design review have not been established.
Procedures for design review have not been adequately established.
Procedures for design review have not been adequately established.
Procedures for design review have not been adequately established.
Procedures for design review 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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