FDA WARNING_LETTER - Waiakea Bottling Inc. - February 14, 2024

The FDA inspected Waiakea Hawaiian Volcanic Water's facility in Hilo, HI, from December 19, 2023, to February 14, 2024, revealing significant violations of 21 CFR Part 129 (Bottled Drinking Water Regulations) and 21 CFR Part 117 (CGMP & PC rule). These violations render their bottled water products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Ineffective Product Water Treatment (21 CFR 129.80(a)):** The facility's (b)(4) treatment, intended to remove biological hazards, was ineffective. Records showed (b)(4) readings indicating poor performance, far exceeding manufacturer specifications. This was corroborated by consumer complaints of foreign material (mold, white blob, floaters) and third-party lab analyses of Waiakea Hawaiian Volcanic Water, lot WB123275, which found high levels of heterotrophic plate count (>5700 CFU/mL), Pseudomonas aeruginosa (>2400 MPN/100mL), mold (15 CFU/mL), Paecilomyces lilacinus, and other fungal species. FDA analysis of the same lot identified yeast and mold counts up to 16,000 YMC/mL. The firm