FDA 483 OBSERVATION · #986 OF 1,000 MOST-CITED
Design plans- updated
FDA cited this observation 17 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
Design plans were not reviewed, updated and approved as design and development evolves.
Design plans were not reviewed and approved as design and development evolves.
Design plans were not updated as design and development evolves.
Design plans were not approved as design and development evolves.
Design plans were not updated and approved as design and development evolves.
Design plans were not as design and development evolves.
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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