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Department of Health and Human Services Public Health Service Food and Drug Administration NAME AND LOCATION OF PLANT MILK PLANT INSPECTION REPORT (Includes Dry Milk/Condensing Plants, Receiving Stations,
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Form FDA 2359 is a form used by manufacturers, packers, and distributors of drugs and biologics to report any serious adverse events or product deviations to the Food and Drug Administration (FDA).
Manufacturers, packers, and distributors of drugs and biologics are required to file form FDA 2359.
To fill out form FDA 2359, you need to provide information such as the identity of the drug or biologic, the nature of the adverse event or product deviation, the patient's details, and the person reporting the event. The form can be filled out electronically or manually.
The purpose of form FDA 2359 is to ensure that the FDA receives timely and accurate information about serious adverse events or product deviations associated with drugs and biologics. This information helps the FDA monitor the safety and quality of these products.
The information that must be reported on form FDA 2359 includes the identity of the drug or biologic, the nature of the adverse event or product deviation, the patient's details, and the person reporting the event. Additional information may be required depending on the specific circumstances.
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