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FDA issues warnings to water company over mold contamination and infant formula producer lacking Cronobacter testing

September 9, 2024 from Food Safety News:

"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.

"n 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, such as “mold,” “white blobs,” and “floaters,” with laboratory tests confirming microbial contamination. Despite responses and corrective actions proposed by the company, the FDA found that the measures taken were insufficient to address the identified violations.

The full warning letter can be seen here"