FDA 483 OBSERVATION · #85 OF 1,923 MOST-CITED
Specifications met - verify; finished batch
FDA cited this observation 323 times across 261 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 verify that a subset of finished dietary-supplement batches met product specifications (through appropriate testing), so conformance of the finished product was not confirmed.
Why FDA writes it — Specifications mean nothing without verification. The rule requires testing a subset of finished batches to confirm they meet specifications; skipping it means the finished product is released without evidence it actually conforms.
- Verify that a subset of finished dietary-supplement batches (identified through a sound statistical sampling plan, or every batch) meets product specifications for the attributes that can be tested.
- Use scientifically valid methods appropriate to the attribute.
- For specifications that cannot be verified by testing the finished product, ensure they are met through in-process controls.
- Reject and investigate batches that do not meet specifications.
- No finished-batch verification testing, so conformance is asserted rather than demonstrated.
- A sampling plan without a sound statistical basis.
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 3.7× the rate of the average FDA-cited firm (28.3% vs 7.8%), across 261 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 verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition.
You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition.
You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition.
You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition and limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement.
You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition.
You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition.
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 →