Preferred Label : FDA Warning Letter;
NCIt related terms : Warning Letter;
NCIt definition : A written communication from FDA notifying an individual or firm that the agency considers
one or more products, practices, processes, or other activities to be in violation
of the Federal FD&C Act, or other acts, and that failure of the responsible party
to take appropriate and prompt action to correct and prevent any future repeat of
the violation may result in administrative and/or regulatory enforcement action without
further notice. (FDA);
Alternative definition : CDISC-GLOSS: A written communication from FDA notifying an individual or firm that
the agency considers one or more products, practices, processes, or other activities
to be in violation of the Federal FD&C Act, or other acts, and that failure of the
responsible party to take appropriate and prompt action to correct and prevent any
future repeat of the violation may result in administrative and/or regulatory enforcement
action without further notice. [FDA];
NCI Metathesaurus CUI : CL540494;
Origin ID : C142556;
UMLS CUI : C4684670;
Semantic type(s)
- concept_is_in_subset
