Holi Hemp LLC – FDA 483, Nov 19, 2024

An FDA inspection conducted between November 13 and November 19, 2024, at an unnamed firm revealed significant deficiencies in quality control and manufacturing practices, particularly concerning hand sanitizer production. The primary findings outlined in the FDA Form 483 indicate a lack of a functional quality control unit, as personnel responsible for quality were unavailable and management could not address quality system attributes.Key violations include the absence of written and followed procedures for quality control, with existing SOPs designed for dietary supplements rather than current drug product manufacturing. The firm failed to conduct essential testing on hand sanitizer products to ensure conformance to final specifications, identity, and strength, and similarly neglected to test raw ingredients like Glycerin. Environmental controls for manufacturing were not established. Furthermore, production and process control procedures were inadequate and not systematically applied. Hand sanitizer products were found with arbitrary expiration dates, lacking supporting stability data. Critical manufacturing records were not readily available, and access to label storage was not restricted to authorized personnel.These observations highlight non-compliance with regulatory expectations under the Federal Food, Drug, and Cosmetic Act, necessitating immediate corrective actions. The firm is required to establish a robust quality control unit, implement comprehensive testing protocols for both raw materials and finished products, develop and follow adequate manufacturing procedures, conduct stability studies to determine accurate expiration dates, ensure complete record-keeping, and secure label storage areas. These actions are crucial to ensure product quality, safety, and regulatory adherence.