FDA 483 OBSERVATION · #1464 OF 1,916 MOST-CITED
Legible reproductions
FDA cited this observation 8 times across 8 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
Legible reproductions of all labels and hazard warnings required by the regulations were not provided with the laser product.
Legible reproductions of all labels and hazard warnings required by the regulations were not provided with the laser product.
Legible reproductions of all labels and hazard warnings required by the regulations were not affixed to the laser product, were not provided with the laser product and did not include the information required for positions 1, 2, and 3 of the logotype specified in the CFR.
Legible reproductions of all labels and hazard warnings required by the regulations were not provided with the laser product and did not include the information required for positions 1, 2, and 3 of the logotype specified in the CFR.
Legible reproductions of all labels and hazard warnings required by the regulations.
Legible reproductions of all labels and hazard warnings required by the regulations were not provided with the laser 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 →