FDA WARNING_LETTER - Health And Natural Beauty USA Corp - October 15, 2024

The FDA issued a Warning Letter to Health and Natural Beauty USA Corp. following an inspection of their Piscataway, New Jersey drug manufacturing facility from October 9 to 15, 2024. The letter details significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products, including SprinJene oral healthcare toothpastes, adulterated. The FDA also classified these products as unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

Key violations include the failure to adequately test incoming drug product components. Specifically, the company did not conduct identity testing for high-risk ingredients like glycerin and sorbitol solution for diethylene glycol (DEG) or ethylene glycol (EG) contamination, which can be lethal. They also failed to test active ingredients such as sodium fluoride. Additionally, the firm lacked established adequate written procedures for production and process control, indicating a failure to validate manufacturing processes.

The FDA requires Health and Natural Beauty USA Corp. to take prompt corrective actions. These include providing DEG/EG test results for all at-risk components or finished products, conducting a comprehensive risk assessment, and initiating recalls if contamination is found. The company must implement robust corrective and preventive actions to secure their supply chain, ensure all raw materials are from qualified manufacturers and free from impurities, and establish reliable component testing procedures, including a specific identity test for each incoming lot. Furthermore, the firm must adequately validate all production and process controls and provide documentation of these changes and their effectiveness.