FDA 483 OBSERVATION · #785 OF 1,932 MOST-CITED
Route of administration
FDA cited this observation 25 times across 25 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
Administration of an approved animal drug via a route, subcutaneous, which was not indicated in the labeling, without benefit of a valid veterinarian-client-patient relationship.
Administration of an approved animal drug via a route, intramuscular, which was not indicated in the labeling, without benefit of a valid veterinarian-client-patient relationship.
Administration of an approved animal drug via a route, topical, which was not indicated in the labeling, without benefit of a valid veterinarian-client-patient relationship.
Administration of an approved animal drug via a route, intramuscular, which was not indicated in the labeling, without benefit of a valid veterinarian-client-patient relationship.
Administration of an approved animal drug via a route, intramuscular, which was not indicated in the labeling, without benefit of a valid veterinarian-client-patient relationship.
Administration of an approved animal drug via a route, subcutaneous, which was not indicated in the labeling, without benefit of a valid veterinarian-client-patient relationship.
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 →