Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistElemental Herbs Inc. (ALL good) was warned for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of drug products, including failure to establish an adequate quality unit with proper responsibilities and procedures. The company's drug products were deemed adulterated due to non-conforming methods, facilities, and controls, and the product "ALL good Goop Skin Recovery Balm" was identified as an unapproved new drug that was also misbranded. The FDA's February 2023 inspection of the Morro Bay, California facility identified these violations, and the company's subsequent response was found to be inadequate in providing sufficient corrective action details.