FDA 483 OBSERVATION · #392 OF 1,000 MOST-CITED
Actual vs. theoretical yields not determined
FDA cited this observation 50 times across 47 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 4.3× the rate of the average FDA-cited firm (36.2% vs 8.3%), across 47 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
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of packaging of the drug product.
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing of the drug product.
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of of the drug product.
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of processing and packaging of the drug product.
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing, processing and holding of the drug product.
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of of the drug product.
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.
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