Bacteria-infected water used to make toothpaste and a mold-like substance were found at a Tom’s of Maine factory during an inspection earlier this year, according to the Food and Drug Administration.
A warning letter sent to parent company Colgate-Palmolive on Nov. 5 and released on Tuesday outlined the violations found during the May inspection at a production facility in Sanford, Maine.
Three different types of bacteria were found in the water at the facility, including the water that’s used to make Tom’s Simply White clean mint toothpaste and Wicked Cool! anticavity toothpaste.
“Batches manufactured after these incidents were released based on the microbial testing of the finished OTC product despite the quality of the water used as a component or to clean the equipment,” the FDA said, noting an inspector also found a “black mold-like substance” on hoses and tanks near other equipment used for toothpaste production.
“Water is a major ingredient in many of your [over-the-counter] drug products,” the letter reads. “It is essential that you employ a water system that is robustly designed, and that you effectively control, maintain and monitor the system to ensure it consistently produces water suitable for pharmaceutical use.”
The company said in a statement that it’s cooperating with the FDA to fix the issues and is “fully confident in the safety and quality of” its products.
