FDA 483 OBSERVATION · #1031 OF 1,932 MOST-CITED
Certification label or tag
FDA cited this observation 17 times across 17 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.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
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. Open the 483 observation explorer →