FDA 483 OBSERVATION · #376 OF 1,000 MOST-CITED
Testing Each Component for Conformity with Specs
FDA cited this observation 52 times across 51 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
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
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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