FDA 483 OBSERVATION · #80 OF 1,923 MOST-CITED
Specifications - finished dietary supplement
FDA cited this observation 330 times across 325 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.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
What this observation means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
A dietary-supplement manufacturer did not establish adequate specifications for the finished batch of dietary supplement, so there was no defined standard the finished product had to meet for identity, purity, strength, composition, and limits on contaminants.
Why FDA writes it — The finished-product specification is the definition of an acceptable dietary supplement. Without it, the manufacturer cannot judge whether a batch is acceptable — release becomes arbitrary, and label claims are unsupported.
- Establish product specifications for the identity, purity, strength, and composition of the finished batch of dietary supplement, and for limits on contaminants.
- Establish specifications that ensure the label claims are met.
- Verify that finished batches meet the specifications (or, with a documented exemption, meet the requirements for exemption).
- Reject batches that do not meet specifications.
- No finished-product specifications, so release has no acceptance standard.
- Specifications that do not actually ensure the label claims are met.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 2.2× the rate of the average FDA-cited firm (17.2% vs 7.8%), across 325 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
You did not establish product specifications for identity, purity, strength and composition.
You did not establish product specifications for identity, purity, strength and limits on contamination.
You did not establish product specifications for identity, purity, strength and composition.
You did not establish product specifications for identity, purity, strength, composition and limits on contamination.
You did not establish product specifications for identity, purity, strength, composition and limits on contamination.
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. Open the 483 observation explorer →