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

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, 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 viewed here.

Graceleigh Inc. dba Sammy’s Milk
Newport Beach, CA

On Aug. 14, 2024, the FDA issued a warning letter to Graceleigh Inc., doing business as Sammy’s Milk in Newport Beach, CA. The FDA inspection found that Sammy’s Milk violated the Federal Food, Drug, and Cosmetic Act by marketing its goat milk product as an infant formula without providing the required 90-day notification to the FDA. Sammy’s Milk was represented as suitable for infants on the company’s website and social media platforms, leading to its classification as a non-notified infant formula.

The FDA also found that the product was misbranded, as claims on the company’s website falsely stated that Sammy’s Milk had been tested for Cronobacter, a serious contaminant. However, during the FDA’s inspection of the contract manufacturer, it was revealed that no such testing had been conducted. Sammy’s Milk subsequently issued a recall and removed some claims from their website, but the FDA remains concerned about misleading representations that suggest the product is safe for infant consumption.

The full warning letter can be viewed here.

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