FDA 483 OBSERVATION · #70 OF 1,923 MOST-CITED
Specifications-component purity, strength, composition
FDA cited this observation 355 times across 296 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 drug manufacturer did not establish or follow adequate specifications for the purity, strength, and composition of components (and did not adequately test against them), so incoming materials were not confirmed to meet requirements before use.
Why FDA writes it — A drug can only be as good as its components. Without adequate component specifications and testing for purity, strength, and composition, the firm cannot assure the starting materials are what they should be — and defects enter the product at the source.
- Establish scientifically sound specifications for the identity, purity, strength, quality, and, where applicable, composition of components.
- Test or examine components against those specifications (identity by your own testing; other attributes may rely on a qualified supplier’s COA with periodic verification).
- Approve or reject components based on the results, and quarantine until dispositioned.
- Justify and control specification limits and any changes to them.
- Relying on supplier certificates without establishing or verifying component specifications.
- Using components before they are tested and approved against specifications.
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 4.2× the rate of the average FDA-cited firm (32.4% vs 7.8%), across 296 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 component specifications for purity and strength.
You did not establish component specifications for purity, strength and composition.
You did not establish component specifications for purity, strength and composition.
You did not establish component specifications for strength and composition.
You did not establish component specifications for purity, strength and composition.
You did not establish component specifications for 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 →