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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 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 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 ...
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 ...
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 ...
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize it is of ...
FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs. The Office of Global Regulatory Operations and Policy (GO), [1] also known as the Office of Regulatory Affairs (ORA), [2] is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation ...
On Monday, the FDA released a warning letter addressed to Amazon CEO Andrew Jassy noting that the e-commerce website was selling seven brands of eye drops marketed as treatments for conditions ...