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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:
Structures, Names and Identifiers, Chemical and Physical Properties, Spectral Information, Related Records, Chemical Vendors, Pharmacology and Biochemistry, Use and Manufacturing, Safety and Hazards, Toxicity, Literature, Patents, Biomolecular Interactions and Pathways, Biological Test Results
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 ...
The FDA suggests providers to move away from the use of Getinge's Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and its Cardiohelp system and HLS Sets.
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 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.
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 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 ...