FDA 483 OBSERVATION · #607 OF 1,000 MOST-CITED
Specifications met identity,purity, strength, comp,; basis
FDA cited this observation 30 times across 29 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 provide adequate documentation of your basis for determining that compliance with the specification s you selected for identity, purity, strength, and composition will ensure that the finished batch of dietary supplement meets the specification s.
You did not provide adequate documentation of your basis for determining that compliance with the specification you selected for identity, purity, strength, and composition will ensure that the finished batch of dietary supplement meets the specification.
You did not provide adequate documentation of your basis for determining that compliance with the specification s you selected for identity, purity, strength, and composition will ensure that the finished batch of dietary supplement meets the specification.
You did not provide adequate documentation of your basis for determining that compliance with the specification you selected for identity, purity, strength, and composition will ensure that the finished batch of dietary supplement meets the specification.
You did not provide adequate documentation of your basis for determining that compliance with the specification s you selected for identity, purity, strength, and composition will ensure that the finished batch of dietary supplement meets the specification s.
You did not provide adequate documentation of your basis for determining that compliance with the specification you selected for identity, purity, strength, and composition will ensure that the finished batch of dietary supplement meets the specification.
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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