FDA 483 OBSERVATION · #910 OF 1,000 MOST-CITED
Certification label or tag
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
A certification label or tag is not permanently affixed or inscribed.
A certification label or tag is not permanently affixed or inscribed and readily accessible to view when the product is fully assembled for use.
A certification label or tag is not permanently affixed or inscribed.
A certification label or tag is not permanently affixed or inscribed.
A certification label or tag is not permanently affixed or inscribed.
A certification label or tag is not permanently affixed or inscribed.
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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