Warning Letter definition

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

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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.

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.

Examples of Warning Letter in a sentence

• 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.

• 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 confirm the unsatisfactory performance or conduct, the improvements and timeframe in which the employee is required to meet expected standards and possible consequences of non-compliance.

• If, in spite of two official attendance warnings, the student continues not to comply with the attendance requirements stated in the first two Attendance Warning Letters, the student will be issued a third – and final – Attendance Warning Letter, at which time termination of their Form 1-20 and expulsion from AOI will take place It is the student’s responsibility to be in class on time and ready for instruction at the start of class and after scheduled breaks.

• When a meeting with an employee is being convened for the purpose of discipline (i.e. Warning Letter, Official Letter of Reprimand, suspension, demotion, or discharge) or for the purpose of being interviewed as part of an investigation, the employee shall be advised of his/her right to representation prior to the beginning of any such conference or meeting and shall be given two (2) duty days to arrange for representation.

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 a written notice issued by County staff to notify a party that he or she is in violation of a County Ordinance. The warning letter will inform the party of the alleged violations, the nature and extent of the violations, and the required corrective actions. The warning letter shall be utilized as the initial County notification of alleged violations, except in cases of imminent threat to public health and safety and the environment.

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 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.