FDA 483 OBSERVATION · #72 OF 1,923 MOST-CITED
Specifications - component identity
FDA cited this observation 348 times across 291 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 manufacturer did not conduct at least one specific identity test on each lot of incoming component, so the identity of the material used to make the drug was not confirmed before use.
Why FDA writes it — Identity is the most fundamental component control: if you cannot confirm a component is what it claims to be, nothing downstream can assure the product. FDA requires the manufacturer’s own identity test on each lot precisely because supplier labels and certificates can be wrong.
- Conduct at least one specific identity test on each lot of each component before use.
- For other component attributes (purity, strength, quality), test or rely on a supplier’s report of analysis only after establishing the reliability of that supplier’s analyses through appropriate validation at appropriate intervals.
- Quarantine components until identity and other required attributes are confirmed.
- Reject and document components that fail identity.
- Relying on the supplier’s certificate for identity instead of performing your own identity test.
- Testing a composite rather than confirming each lot’s identity.
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 4.1× the rate of the average FDA-cited firm (32.0% vs 7.8%), across 291 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 an identity specification for each component.
You did not establish an identity specification for each component.
You did not establish an identity specification for each component.
You did not establish an identity specification for each component.
You did not establish an identity specification for each component.
You did not establish an identity specification for each component.
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 →