FDA 483 OBSERVATION · #347 OF 1,000 MOST-CITED
Failing drug products not rejected
FDA cited this observation 60 times across 55 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
Drug products failing to meet established standards, specifications and quality control criteria are not rejected.
Drug products failing to meet established specifications are not rejected.
Drug products failing to meet established standards, specifications and quality control criteria are not rejected.
Drug products failing to meet established standards, specifications and quality control criteria are not rejected.
Drug products failing to meet established standards, specifications and quality control criteria are not rejected.
Drug products failing to meet established standards and specifications are not rejected.
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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