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Waiakea Bottling Inc. was cited for significant violations of bottled drinking water manufacturing regulations (21 CFR Part 129) and Current Good Manufacturing Practice standards (21 CFR Part 117) at its Hilo, Hawaii facility during an inspection from December 2023 through February 2024. The violations rendered the company's bottled water products adulterated because they were processed, packed, or held under insanitary conditions that could lead to contamination or health hazards. The FDA identified failures in preventive controls provisions and treatment processes, with the company submitting responses in March 2024 and a revised Food Safety Plan in April 2024.