The U.S. Food and Drug Administration has issued a warning regarding toothpaste produced by Tom's of Maine Inc., a subsidiary of Colgate-Palmolive Co., due to contamination concerns involving bacteria-laden water used in manufacturing.
Following an inspection conducted from May 7 to May 22 at Tom’s manufacturing site in Sanford, Maine, a warning letter was dispatched highlighting significant regulatory breaches. Inspectors uncovered various issues, including the presence of bacteria in water samples and final products. Contaminants were identified in the water used in Tom's production, with inspectors also noting a black mold-like substance near equipment used for producing over-the-counter (OTC) drugs.
This tainted water was incorporated into the company’s OTC pharmaceutical products and employed as a final rinse during equipment cleaning processes.
The FDA's investigation revealed the presence of Pseudomonas aeruginosa in multiple water samples collected between June 2021 and October 2022. This water was used to produce a specific batch of Tom’s Simply White Clean Mint Paste. Additionally, the bacteria Ralstonia insidiosa and Paracoccus yeei—a gram-negative cocco-bacilli—were identified in water access points, and Paracoccus yeei was found in the Wicked Cool! Anticavity Toothpaste finished product.
The FDA emphasized, "Water is a critical component in many of your OTC drug products. It is imperative that you implement a water system that is robustly designed, effectively controlled, maintained, and monitored to ensure it consistently produces water fit for pharmaceutical use."
The agency further stated that the company had not adhered to written procedures aimed at preventing contamination of drug products with objectionable microorganisms. These products are not mandated to be sterile.
In response, the FDA has requested a comprehensive evaluation of the design and controls of the manufacturing processes, alongside a detailed investigation of all microbiological risks and the root causes of the contamination.
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