Warning Letter definition

Warning Letter. (WL) means an informal written notice of an alleged violation for which formal enforcement is not anticipated.

Warning Letter is a letter issued by the FDA for an alleged violation of regulatory significance that provides individuals and firms an opportunity to take voluntary corrective action.

Warning Letter means a letter characterized by the FDA or any other Regulatory Agency as a warning letter, a notice of adverse finding, observation of noncompliance or a similar letter or report in which FDA or any other Regulatory Agency expresses the opinion that violations of law, regulation or guideline have occurred.

Examples of Warning Letter in a sentence

• We are addressing inspectional observations on Form 483 and a Warning Letter issued by the U.S. Food and Drug Administration (“FDA”) following its previous inspections of our Warsaw North Campus facility, among other matters.

• EURAND shall provide RELIANT with immediate notification of its receipt of any of the following related to the manufacture, production or testing of Product: a copy of any list of observations (Form FD 483), Warning Letter, Information Letter, Regulatory Letter or the like issued by the FDA as well as provide RELIANT an opportunity to review any written response prior to submission to the issuing agency.

• We are addressing inspectional observations on Form 483 and a Warning Letter issued by the U.S. Food and Drug Administration (“FDA”) following its inspections of our Warsaw North Campus facility, among other matters.

• We addressed inspectional observations on Form 483 and a Warning Letter issued by the U.S. Food and Drug Administration (“FDA”) following its previous inspections of our Warsaw North Campus facility, among other matters.

• Arena shall use Commercially Reasonable Efforts to resolve as soon as possible any issues that arise in its seeking or maintaining Facility Licenses, including completely addressing and rectifying any deviations or other issues raised in any Warning Letter from the FDA or any similar warning or objection by any other Regulatory Authority.

More Definitions of Warning Letter

Warning Letter means a written communication from the MTA to one or more persons concerning acts and omissions prohibited by this chapter.

Warning Letter or “WL” means a type of Notice of Alleged Violation under Va. Code

Warning Letter means any letter issued by the FDA notifying a party that, upon inspection, it has been found to be in violation of one or more FDA regulations, or any letter issued by the FTC notifying a party that it has been found to be in violation of one or more provisions of the FTC Act.

Warning Letter means an official FDA correspondence notifying a firm or individual that FDA considers such firm or individual to be in violation of the FDCA, its implementing regulations, or other federal statutes, and is issued for violations of regulatory significance (i.e., violations that may lead to an FDA enforcement action if the documented violations are not promptly and adequately corrected) to allow such firm or individual to take voluntary corrective action.

Warning Letter means a letter issued by the FDA for any violation of regulatory significance.

Warning Letter shall have the meaning ascribed to it by FDA policy, as the same may be amended or changed from time to time.

Warning Letter means a written description signed by the Director of a violation of this Title and the necessary corrective action. A Warning Letter cannot be used to assess civil penalties, is not appealable to the Commission, and is not final agency action.