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An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.
Warning letters were issued to each of the four companies requiring them to provide to the FDA in writing within 15 days of the specific steps the firms will be taking. Manufacturers have argued that drinking a caffeinated alcoholic energy drink is indistinguishable from drinking a couple of glasses of wine followed by a couple of cups of coffee.
The FDA's warning letters are not associated with any current recalls, and were related to observations following recalls by the three companies between December and March, the agency said.
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
The FDA said it inspected the firms earlier this year and found pervasive failures with data management, quality assurance, staff tra US FDA sends warning letters to two Chinese firms for ...
An FDA warning to Bimbo Bakeries over ingredients and allergens on bread labels comes after a Kansas food safety and processing inspection in Topeka.
The U.S. Food and Drug Administration issued warning letters to five electronic cigarette distributors, saying the products are being marketed illegally as safer alternatives to smoking and even ...
The drug regulator during its inspection determined that Cardinal was an importer of two types of syringes sold under the Monoject brand. US FDA sends warning letter to Cardinal Health for ...