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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 ...
When the FDA conducted an inspection of Baxter's Chinese heparin supplier, it found serious deficiencies at the facility, which the FDA detailed in a warning letter. [9] [10] The warning letter detailed that the company failed to monitor changes in the impurity profile of incoming heparin active raw material, to adequately investigate out-of ...
The FDA sent a warning letter Nov. 5 to parent company Colgate-Palmolive, which was publicly released Tuesday, detailing how microorganisms were found in water samples and finished toothpaste ...
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 ...
An FDA warning to Bimbo Bakeries over ingredients and allergens on bread labels comes after a Kansas food safety and processing inspection in Topeka.
FDA preemption; FDA recall policies; FDA v. Alliance for Hippocratic Medicine; FDA v. Brown & Williamson Tobacco Corp. FDA warning letter; Federal Food, Drug, and Cosmetic Act of 1938; First-in-class medication; Food Additives Amendment of 1958; Food and Drug Administration Amendments Act of 2007; Food and Drug Administration Modernization Act ...
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 ...