FDA 483 OBSERVATION · #1229 OF 1,932 MOST-CITED
Class IV "Danger" label
FDA cited this observation 12 times across 12 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
Each Class IV laser product does not have affixed a label bearing the DANGER logotype specified in the regulation and bearing the wording "LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION" in the position specified in the regulation.
Each Class IV laser product does not have affixed a label bearing the DANGER logotype specified in the regulation, bearing the wording "LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION" in the position specified in the regulation and bearing the wording "CLASS IV LASER PRODUCT" in the position specified in the regulation.
Each Class IV laser product does not have affixed a label bearing the DANGER logotype specified in the regulation.
Each Class IV laser product does not have affixed a label bearing the DANGER logotype specified in the regulation.
Each Class IV laser product does not have affixed a label bearing the DANGER logotype specified in the regulation, bearing the wording "LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION" in the position specified in the regulation and bearing the wording "CLASS IV LASER PRODUCT" in the position specified in the regulation.
Each Class IV laser product does not have affixed a label bearing the wording "LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION" in the position specified in the regulation.
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 →