FDA 483 - Holi Hemp LLC - November 19, 2024

Holi Hemp LLC, a drug manufacturer in Vancouver, WA, was cited with nine observations during an FDA inspection. The firm lacked a defined and functional quality control unit, failed to conduct essential testing for both finished hand sanitizer products and raw materials, and did not establish adequate environmental controls or proper written procedures for drug manufacturing. Additionally, issues included unsupported expiration dates, unavailable records, and uncontrolled access to labeling materials, indicating significant deficiencies in their quality system and manufacturing practices.