FDA 483 OBSERVATION · #362 OF 1,000 MOST-CITED
Adequate number of batches on stability
FDA cited this observation 75 times across 68 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 observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 6.1× the rate of the average FDA-cited firm (47.1% vs 7.7%), across 68 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
An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.