The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters.
Warning letters often are not issued until a company has been given months to years to correct problems. The U.S.
Food and Drug Administration (FDA) recently issued warning letters to Waiakea Bottling Inc. and Graceleigh, Inc., doing business as Sammy’s Milk, for serious violations of food safety regulations.
The violations pose potential risks to public health, emphasizing the need for compliance with FDA regulations. Waiakea Bottling Inc. Culver City, CA On Aug.
13, 2024, the FDA issued a warning letter to Waiakea Bottling Inc . , based in Culver City, CA, following an inspection of its bottled water manufacturing facility in Hilo, Hawaii. The inspection, which took place from Dec.
19, 2023, through Feb. 14, 2024, revealed significant violations of the Processing and Bottling of Bottled Drinking Water regulations and Current Good Manufacturing Practice (CGMP) requirements. The violations at Waiakea’s facility rendered the bottled water products adulterated due to the presence of contaminants like mold, Pseudomonas aeruginosa, and various fungal species, including Aspergillus versicolor and Penicillium simplicissimum.
The firm received consumer complaints about foreign material in bottled water, .