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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 Food and Drug Administration (FDA) announced in a statement Tuesday that it has sent warning letters to companies selling unapproved weight loss drugs. The letter went to Xcel Peptides ...
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.
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 ...
According to the letter, Tom's of Maine determined that the Wicked Cool! toothpaste had P. yeei bacteria "due to sample contamination," and that the batch was released after retesting, but the FDA ...
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 ...
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 batch was released based on retest results,” the warning letter said. An FDA investigator also observed a “black mold-like substance” at the base of a hose reel and behind a water ...