FDA 483 OBSERVATION · #65 OF 1,923 MOST-CITED
Lack of written stability program
FDA cited this observation 373 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 drug manufacturer lacked a written stability-testing program (or an adequate one) designed to assess the stability characteristics of drug products and to support their labeled expiration dates and storage conditions.
Why FDA writes it — The expiration date is a promise that the product remains within specification until then. Without a written stability program using stability-indicating methods, that promise is unsupported — the firm cannot demonstrate the product stays safe and effective through its shelf life.
- Establish a written stability-testing program to assess stability characteristics and determine appropriate storage conditions and expiration dates.
- Use reliable, meaningful, and specific (stability-indicating) test methods.
- Test in the container-closure system in which the product is marketed, at appropriate intervals.
- Place at least one batch per year on an ongoing (commitment) stability program where applicable, and act on adverse trends.
- Expiration dates set without a written, stability-indicating program behind them.
- Stability studied in a different container-closure than the marketed product.
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 6.7× the rate of the average FDA-cited firm (51.9% 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
There is no written testing program designed to assess the stability characteristics of drug products.
There is no written testing program designed to assess the stability characteristics of drug products.
There is no written testing program designed to assess the stability characteristics of drug products.
There is no written testing program designed to assess the stability characteristics of drug products.
There is no written testing program designed to assess the stability characteristics of drug products.
There is no written testing program designed to assess the stability characteristics of drug products.
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 →