FDA 483 OBSERVATION · #386 OF 1,000 MOST-CITED
Master manufacturing record theoretical and expected yield
FDA cited this observation 51 times across 51 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 2.8× the rate of the average FDA-cited firm (23.5% vs 8.3%), across 51 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
Your master manufacturing record did not include a statement of the theoretical yield for each point, step, or stage of the manufacturing process to ensure quality control.
Your master manufacturing record did not include a statement of the theoretical yield for each point, step, or stage of the manufacturing process to ensure quality control.
Your master manufacturing record did not include a statement of the theoretical yield for each point, step, or stage of the manufacturing process to ensure quality control.
Your master manufacturing record did not include a statement of the theoretical yield for each point, step, or stage of the manufacturing process to ensure quality control and the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made.
Your master manufacturing record did not include a statement of the theoretical yield for each point, step, or stage of the manufacturing process to ensure quality control and the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made.
Your master manufacturing record did not include a statement of the theoretical yield for each point, step, or stage of the manufacturing process to ensure quality control.
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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