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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DI STRICT ADDRESS ANO PHONE NUMERATE(S) OF INSPECTIONS Cu s t on house Rrn900 200 Chest nut St Philadelphia, PA 1 9 1 06 (215)5974390
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O-fdanews is a form required by the FDA for certain regulated products.
Manufacturers, distributors, and importers of regulated products are required to file o-fdanews.
O-fdanews must be completed online through the FDA's electronic submission system.
The purpose of o - fdanews is to provide the FDA with important information about regulated products.
Information such as product name, manufacturer information, ingredient list, intended use, and adverse event reports must be reported on o - fdanews.
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