FDA 483 OBSERVATION · #978 OF 1,000 MOST-CITED
Labeled directions - not followed
FDA cited this observation 14 times across 14 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.
How FDA worded it — real examples
You did not use an approved drug according to directions specified in its labeling for dosage and frequency or duration of treatment and you did not have a lawful order under a valid veterinary client-patient relationship.
You did not use an approved drug according to directions specified in its labeling for dosage, frequency or duration of treatment, route of administration and conditions of use and you did not have a lawful order under a valid veterinary client-patient relationship.
You did not use an approved drug according to directions specified in its labeling for species or class of animal and you did not have a lawful order under a valid veterinary client-patient relationship.
You did not use an approved drug according to directions specified in its labeling for withdrawal period and you did not have a lawful order under a valid veterinary client-patient relationship.
You did not use an approved drug according to directions specified in its labeling for withdrawal period and you did not have a lawful order under a valid veterinary client-patient relationship.
You did not use an approved drug according to directions specified in its labeling for dosage and you did not have a lawful order under a valid veterinary 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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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