FDA 483 OBSERVATION · #73 OF 1,000 MOST-CITED
Specifications - finished dietary supplement
FDA cited this observation 286 times across 281 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 establish product specifications for composition.
You did not establish product specifications for identity.
You did not establish product specifications for purity.
You did not establish product specifications for identity, purity, strength, composition and limits on contamination.
You did not establish product specifications for identity, purity and strength.
You did not establish product specifications for identity, purity, strength, composition and limits on contamination.
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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