FDA 483 - Waiakea Bottling Inc - February 14, 2024

Waiakea Bottling Inc, a bottled water manufacturer in Milo, HI, received a Form 483 with six observations. The inspection revealed significant deficiencies in the firm's food safety plan reanalysis, sanitizing operations, product water treatment effectiveness, and hazard analysis, particularly concerning microbial and foreign object contamination. These issues led to consumer complaints, lab findings of pathogens, and product destruction.