FDA 483 - Holi Hemp LLC - November 19, 2024

During an inspection conducted from November 13 to November 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Holi Hemp LLC, a drug manufacturer in Vancouver, WA. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations, indicating a lack of adequate controls for drug product quality and safety.Key observations included the absence of a defined and effective quality control unit, with personnel unable to address quality system attributes or provide requested documentation. The company lacked written procedures specifically applicable to a quality control unit for drug manufacturing, instead relying on general dietary supplement SOPs that were not consistently followed. A major concern was the complete lack of testing for finished hand sanitizer products and raw materials like glycerin, failing to ensure products met identity, strength, and final specifications.Furthermore, Holi Hemp LLC had not established environmental controls for manufacturing areas, lacked adequate written procedures for production and process controls, and failed to assign expiration dates based on appropriate stability data. Incomplete records for drug production and distribution were not readily available, and access to label storage was not restricted to authorized personnel. These observations highlight a systemic failure to implement fundamental quality systems required for drug manufacturing under the Federal Food, Drug, and Cosmetic Act. The company is expected to provide a comprehensive response detailing corrective and preventive actions to address these serious deficiencies.