Loading…
Health and Natural Beauty USA Corp. was cited for significant Current Good Manufacturing Practice (CGMP) violations at its Piscataway, New Jersey facility during an October 2024 inspection, rendering its SprinJene oral healthcare products (including fluoride and children's toothpastes) adulterated under federal law. The company's SprinJene drug products were also found to be unapproved new drugs and misbranded, in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The FDA determined that the company's manufacturing methods, facilities, and controls failed to conform to CGMP regulations (21 CFR parts 210 and 211), and the company's November 2024 response to the FDA 483 inspection observations was deemed inadequate due to insufficient supporting documentation and corrective action evidence.