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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. The FDA defines an FDA warning letter as:
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 ...
On November 17, 2010 the U.S. Food and Drug Administration issued a warning letter to four manufacturers of caffeinated alcoholic beverages citing that the caffeine added to their malt alcoholic beverages is an "unsafe food additive" and said that further action, including seizure of their products, could be taken under federal law. [33]
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 agency also sent a warning letter to Veronvy, which offers unapproved and misbranded oral GLP-1 products, including one that claims to be approved by the FDA. US FDA warns online vendors ...
The FDA gave the company 15 working days to respond to the warning letter. This article originally appeared on Milwaukee Journal Sentinel: Brenntag Great Lakes receives FDA warning letter over ...
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 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 ...