FDA WARNING_LETTER - Hawaii Pharm LLC - November 07, 2019

The FDA inspected Hawaii Pharm's facility in Honolulu, HI, from October 30 to November 7, 2019, identifying serious violations of the Federal Food, Drug, and Cosmetic Act and applicable regulations. The firm's dietary supplement products are deemed adulterated under 21 CFR Part 111 (CGMP) due to failures in establishing identity specifications for components, finished product specifications, preparing Master Manufacturing Records (MMRs) and Batch Production Records (BPRs), maintaining written complaint procedures, and collecting reserve samples. Additionally, products containing *Sida cordifolia* (Bala) are adulterated under section 402(f) for presenting an unreasonable risk due to ephedrine alkaloids. Several products are also misbranded under section 403 and 21 CFR Part 101 for lacking a domestic address/phone for adverse event reporting, failing to list other ingredients, non-compliant Supplement Facts labels (e.g., incorrect daily value statements), and not identifying plant parts for botanical ingredients. The firm's November 20, 2019, response was inadequate due to a lack of supporting documentation. The FDA also noted concerns about *Asarum Splendens* (Wild Ginger) as a potential source of aristolochic acid. Hawaii Pharm must take prompt corrective actions and respond within fifteen working days with detailed steps and documentation to prevent recurrence, or face legal action including seizure and injunction.