FDA 483 OBSERVATION · #62 OF 1,923 MOST-CITED
Component - verify identity, dietary ingredient
FDA cited this observation 406 times across 339 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 conduct at least one appropriate test or examination to verify the identity of a dietary ingredient before using it — the identity of an incoming component was not confirmed.
Why FDA writes it — Identity confirmation is the foundational control in dietary-supplement CGMP: if you cannot confirm a dietary ingredient is what it is supposed to be, nothing downstream can assure the product’s identity or safety. FDA cites this because unverified ingredient identity undermines the entire batch.
- Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, before use.
- Establish and verify component specifications for identity, purity, strength, and composition.
- Qualify a supplier’s certificate of analysis before relying on it in lieu of testing for non-identity specifications — but identity requires your own test/examination.
- Quarantine components until identity and specifications are confirmed.
- Relying solely on a supplier certificate for dietary-ingredient identity rather than testing/examining it.
- Using components before identity verification is complete.
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 (28.6% vs 7.8%), across 339 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 conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
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 →