Supplement Own-Labeler’s GMP Stumble Reveals AER Slip

摘要

FDA warns own-labelers ProSupps USA and Cape Fear Naturals about GMP violations, also pointing out ProSupps dropped the ball on submitting serious AERs to FDA and Cape Fear Naturals made drug claims including “improve blood pressure and cholesterol.” FDA finds two more own-label dietary supplement marketers with good manufacturing practices problems, including one also warned about slipping on submitting serious adverse event reports to the agency.