FDA 483 OBSERVATION · #50 OF 1,000 MOST-CITED
ELDU - producer causes Illegal drug residue
FDA cited this observation 378 times across 363 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
Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance.
Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance.
Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance.
Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance.
Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance.
Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance.
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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