FDA 483 OBSERVATION · #1776 OF 1,916 MOST-CITED
ID label lacks name and address
FDA cited this observation 5 times across 5 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
An identification label failed to provide the name and address of the.
An identification label failed to provide the name and address of the manufacturer and individual or company under whose name the product was sold.
An identification label failed to provide the name and address of the individual or company under whose name the product was sold.
An identification label failed to provide the name and address of the manufacturer.
An identification label failed to provide the name and address of the manufacturer.
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 →