Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistEverlaan Organics, Inc. dba Maple Organics, a Canadian OTC drug manufacturer, was cited for multiple violations including significant Current Good Manufacturing Practice (CGMP) deficiencies that rendered their drug products adulterated. The company's "Joint Pain Relief" and "Muscle Pain Relief" products were found to be unapproved new drugs marketed in violation of federal law, while four products—including "Cough & Cold Relief" formulations—were determined to be misbranded due to inadequate labeling and missing required information. These violations stemmed from the company's methods, facilities, and controls for manufacturing and processing not conforming to FDA requirements under 21 CFR parts 210 and 211.