Warning letter symbols.The following symbols are used to flag certain warning letters containing alleged violations of specific FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. regulations and policies of current interest:
510(k)--Failure to file 510(k)
API--Active Pharmaceutical ingredient
BiMo--IRB, sponsor/monitor, CRO, clinical investigator A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under issues
Comp/Soft--Computer software validation
E-Sig--21 CFR CFR
See: Cost and Freight Part 11, Electronic signature/ records rule.
F-B--Lack of fair balance in promotions
H2O--Water quality issues
MDR--Medical device reporting violations
NDA--Lack of new drug application
O-L Use--Off-label use
PMA--Lack of premarket approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device.
QC/QS--QC/quality systems deviations
S-HACCP--Violations of HACCP HACCP
hazard analysis critical control points. requirements for seafoods
Web--Internet promotion irregularities