Glossary
Active Ingredient
A component of a medicine intended to exert a pharmacological action or other direct effect in the diagnosis, treatment, or prevention of disease.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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1 Based on the records and information you provided, you did not demonstrate that you are testing your active ingredient ethanol for methanol.
FDA · FDA Warning Letter · 2024-05-14 -
Your firm failed to test your incoming components for identity prior to manufacturing your over-the-counter (OTC) drug products (e.g., active ingredients, glycerin, and water as a component)…
FDA · FDA Warning Letter · 2023-08-01 -
You also did not demonstrate that you are adequately testing your active ingredient ethanol for…
FDA · FDA Warning Letter · 2024-05-07
