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Definitions for "Warning Letter"
Keywords:  fda, serious, notifying, postaudit, notice
Related Terms: Recall, No-action letter, Notice of violation, Enforcement, Civil penalty, Citation , Sanction, Whistleblower, Violation, Technical violation, Disciplinary action, Sanctions, Retaliation, Crime, Enforcement, Penal code, Cease and desist order, Promulgate, Criminal law, Prior restraint, Decriminalization, Violation, Administrative order, Violation of this statute, Infraction, Notice, Ex post facto law, Legal notice, Rule, Notice of intent, Bill of attainder, Remediation, Mitigation, Offender , Decision, Reprimand, Complaint, Caution, Traffic infraction, Noncompliance, Nonfeasance, Office action, Misfeasance, Penal, Misconduct, Police caution, Noi, Malfeasance, Declaration
The most serious FDA postaudit (after inspection) letter notifying a manufacturer of adverse finding and giving it 15 days to reply.
pharmaceutical-drug-manufacturers.com
an official notice to a regulated business establishment that objectionable conditions or practices have been identified in their operations, that corrections are expected, and that failure to correct the deficiencies may result in further FDA actions
fda.gov
a serious notice to an investigator and demands development of effective corrective actions, with the threat of legal penalties if the actions are not impending
researchcompliance.uc.edu
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