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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 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 ...
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 ...
The U.S. Food and Drug Administration in 2023 recommended against the use of some China-made syringes as it investigated reports of leaks, breakages and other quality problems with such products ...
The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". [1] Form FDA 483 , [ 2 ] "Inspectional Observations", is a form used by the FDA to document and communicate concerns discovered during these inspections.
The U.S. Food and Drug Administration has issued a warning to three baby formula manufacturers after finding they violated quality-control practices.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
An FDA warning to Bimbo Bakeries over ingredients and allergens on bread labels comes after a Kansas food safety and processing inspection in Topeka.