Warning Letter

All posts tagged Warning Letter

FDA warning letters, known as Form FDA 483 is defined as

…a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act

They demand a prompt response from the organisation/company that receives such a letter. You can search the letters which are all published on the FDA website by clicking here.

 

Here is a link on the FDA website of an example of a warning letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm369495.htm

25-09-2013 13-25-30

And some more info and FAQ’s related to FDA 483 forms and Warning Letters

http://en.wikipedia.org/wiki/Form_FDA_483

https://en.wikipedia.org/wiki/FDA_Warning_Letter

http://www.fda.gov/ICECI/EnforcementActions/ucm256377.htm