FDA 483 OBSERVATION · #1517 OF 1,916 MOST-CITED
Reproduction of affixed information
FDA cited this observation 8 times across 6 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
The manufacturer did not provide or cause to be provided in all descriptive brochures pertaining to each laser product, a legible reproduction of the class designation and the warning required b to be affixed to the product.
The manufacturer did not provide or cause to be provided in all specification sheets and descriptive brochures pertaining to each laser product, a legible reproduction of the class designation, the warning and the information required for positions 1, 2, and 3 of the applicable logotype required b to be affixed to the product.
The manufacturer did not provide or cause to be provided in all specification sheets and descriptive brochures pertaining to each laser product, a legible reproduction of the class designation, the warning and the information required for positions 1, 2, and 3 of the applicable logotype required b to be affixed to the product.
The manufacturer did not provide or cause to be provided in all catalogs and descriptive brochures pertaining to each laser product, a legible reproduction of required b to be affixed to the product.
The manufacturer did not provide or cause to be provided in all catalogs pertaining to each laser product, a legible reproduction of the class designation, the warning and the information required for positions 1, 2, and 3 of the applicable logotype required b to be affixed to the product.
The manufacturer did not provide or cause to be provided in all catalogs, specification sheets and descriptive brochures pertaining to each laser product, a legible reproduction of the class designation and the warning required b to be affixed to the product.
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 →