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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:
Getinge would limit sales of the two products in the U.S. to customers who had no available alternatives, it said. The company has struggled to resolve quality problems with its heart pumps and ...
Getinge is a global medical technology company, founded in Sweden in 1904. The firm provides equipment and systems within healthcare and life sciences.The company was formerly organised in three business areas: Infection Control (trading as Getinge), Extended Care (ArjoHuntleigh) and Medical Systems (Maquet, the world's largest maker of surgical tables), but announced it would become a single ...
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 ...
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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 its ...
The FDA pointed to deficiencies in cleaning and maintenance of equipment to prevent contamination of drug product and also recommended the company review its quality control process, Emergent said.