Warning letter symbols.The following symbols are used to flag certain warning letters containing alleged violations of specific FDA FDAabbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, 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 CAPA--Corrective/preventive action C-H--Complaint handling Cal--Calibration Comp/Soft--Computer software validation The certification that an information system has been implemented correctly and that it conforms to the functional specifications derived from the original requirements. Such validation is often performed by a third party consulting organization. Design--Design controls DTC--Direct-to-consumer advertising E-M--Environmental monitoring F-B--Lack of fair balance in promotions H20--Water quality issues Lab--Labeling issues MDR--Medical device reporting violations NDA--Lack of new drug application O-L Use--Off-label use OOS--Out-of-specification outcomes 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. require-ments for seafoods Stab--Stability Ster--Sterility Val--Validation Web--Internet promotion irregularities |
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