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 Pharmaceutical 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 Pharmaceutical Regulatory Agency expresses the opinion that violations of law, regulation or guideline have occurred.

Examples of Warning Letter in a sentence

• For first time, non-major violations, the Department will issue a Warning Letter that is the equivalent of a Notice of Noncompliance.

• The Warning Letter will identify the violation, and provide a contact telephone number and an investigator’s name so that the association may contact the division for educational assistance or an educational conference in obtaining compliance.

• Limita- tions or other conditions imposed on a federally insured credit union in any written directive from NCUA, includ- ing but not limited to items specified in any Document of Resolution, any published or unpublished Letter of Un- derstanding and Agreement, Regional Director Letter, Preliminary Warning Letter, or formal enforcement action, are unaffected by the adoption of this part.

• The Compliance Team recommended that in response to the issue identified above, Anthem be issued a Warning Letter and one (1) compliance point with no financial penalty, MIP, or CAP.

• Except as set forth on Schedule 4.20(b) of the Disclosure Letter, no Credit Party or its Subsidiaries has received any written notice from any Regulatory Agency citing action or inaction by any Credit Party or any of its Subsidiaries that would constitute a violation of any applicable foreign, federal, state or local laws, rules or regulations, including a Warning Letter or Untitled Letter from FDA.

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 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.

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