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2. FDA warning letter - Wikipedia

   en.wikipedia.org/wiki/FDA_Warning_Letter

   The FDA considers a warning letter informal and advisory. It communicates the agency's position on a matter, but does not commit the FDA to an enforcement action. For that reason, the FDA does not consider a warning letter a final action on which it can be sued. [3]

3. 2008 Chinese heparin adulteration - Wikipedia

   en.wikipedia.org/wiki/2008_Chinese_heparin...

   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 ...

4. Category:Food and Drug Administration - Wikipedia

   en.wikipedia.org/wiki/Category:Food_and_Drug...

   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 ...

5. Bacteria and 'mold-like' substance found at Tom's of Maine ...

   www.aol.com/bacteria-mold-substance-found-toms...

   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 ...

6. US FDA sends warning letters to two Chinese firms for ... - AOL

   www.aol.com/news/us-fda-sends-warning-letters...

   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 ...

7. US FDA sends warning letter to Cardinal Health for marketing ...

   www.aol.com/news/us-fda-sends-warning-cardinal...

   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 ...

8. Office of Global Regulatory Operations and Policy - Wikipedia

   en.wikipedia.org/wiki/Office_of_Global...

   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 ...

9. 3 baby formula companies receive FDA warning letter for ... - AOL

   www.aol.com/3-baby-formula-companies-receive...

   The U.S. Food and Drug Administration has issued a warning to three baby formula manufacturers after finding they violated quality-control practices.