Elemental Herbs, Inc. – FDA 483, Feb 3, 2023

During an inspection from January 23 to February 3, 2023, Elemental Herbs, Inc. received an FDA Form 483 outlining significant observations related to its quality system and product stability for over-the-counter (OTC) drug products, including sunscreens and hand sanitizers. A primary concern was the absence of a quality control unit responsible for crucial functions such as approving or rejecting drug products manufactured under contract. The company also failed to initiate investigations into out-of-specification results from stability testing (e.g., for Zinc Oxide, Ethanol content, and viscosity) and neglected to investigate customer complaints concerning sunburn and allergic reactions, or communicate these with contract manufacturers. Additionally, Elemental Herbs lacked written procedures for key quality unit operations, including the qualification of contract service providers and laboratories, and for conducting investigations, customer complaint handling, and product recalls. The inspection revealed that OTC products were marketed with unsupported expiration dates; many products claimed 3-4 year shelf lives while stability data only supported 2 years. The stability testing program itself was deficient, lacking active annual monitoring for numerous products, failing to evaluate stability in all marketed container-closure systems, and not assessing microbial content at the end of products' shelf life. Elemental Herbs, Inc. is required to address these findings by establishing a robust quality system and ensuring all drug product expiration dates are fully supported by appropriate stability data.