FDA 483 OBSERVATION · #30 OF 1,923 MOST-CITED
Specifications - identity, purity, strength, composition
FDA cited this observation 687 times across 563 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.
The firm did not establish or follow adequate specifications and test methods to assure the identity, strength, quality, purity, and — where applicable — composition of components, in-process materials, and finished products before release.
Why FDA writes it — Specifications are the definition of an acceptable product. Missing, weak, or unfollowed specifications mean the firm cannot demonstrate a released lot actually met what the label and application promise.
- Establish scientifically sound specifications for identity, strength, quality, and purity for components, in-process materials, and finished products.
- Test each batch against the finished-product specification for identity and strength of every active ingredient before release.
- Justify specification limits and any change to them, and control them as approved documents.
- Reject and document any material or batch that fails to meet its specification rather than dispositioning around it.
- Specifications inherited or copied without confirming they suit the specific product and process.
- Release testing that checks some attributes but not every one the specification and regulation require.
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 4× the rate of the average FDA-cited firm (30.9% vs 7.8%), across 563 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 the identity, purity, strength and composition of the finished dietary supplement.
You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.
You did not establish product specifications for the strength and composition of the finished dietary supplement.
You did not establish product specifications for the of the finished dietary supplement.
You did not establish product specifications for the strength of the finished dietary supplement.
You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.
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 →