FDA 483 OBSERVATION · #529 OF 1,000 MOST-CITED
Design plans - Lack of or inadequate
FDA cited this observation 35 times across 34 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
Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.
Design plans that describe or reference the design and development activities and define responsibility for implementation have not been adequately established.
Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.
Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.
Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.
Design plans that describe or reference the design and development activities and define responsibility for implementation 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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