Significant infractions, including bacteria in toothpaste-making water and a black substance resembling mold, were found during an FDA inspection of a Tom’s of Maine production facility.
In a warning letter given to parent firm Colgate-Palmolive on November 5, the FDA described how, during a May inspection of a plant in Sanford, Maine, bacteria were discovered in water samples and completed toothpaste products. The letter was made public on Tuesday.
In a statement released on Wednesday, Tom’s of Maine stated that it is addressing the concerns brought up by the May inspection in collaboration with the FDA.
According to the Centers for Disease Control and Prevention, Pseudomonas aeruginosa, which can lead to lung and blood infections, was found in several water samples between June 2021 and October 2022. According to the letter, that water was utilized to make Tom’s Simply White clean mint paste and as a last rinse for various equipment cleaning procedures.
Additionally, Ralstonia insidiosa bacteria were found in water sources.
The FDA letter stated that, regardless of the quality of the water used as a component or to clean the equipment, batches produced after these incidents were released based on the results of microbiological testing of the final over-the-counter product.
In the last batch of Wicked Cool! anticavity toothpaste, another microbe, Paracoccus yeei, was discovered.
Without providing enough evidence, your investigation came to the conclusion that sample contamination was the cause of the growth. According to the warning letter, the batch was released based on the results of the testing.
At the plant, an FDA investigator also noticed a black, mold-like material under a water storage tank and at the base of a hose reel, both of which were within a foot of machinery used to make toothpaste.
According to the letter, the black material that was discovered in an area prone to “moisture accumulation” was cleaned by Colgate-Palmolive/Tom’s of Maine.
A batch of Tom’s Silly Strawberry anticavity toothpaste was located next to a stainless-steel tray where the investigator also saw powder traces.
The letter cautioned that maintaining hygienic conditions and keeping your facilities in good repair are crucial for safeguarding medication items from possible contamination sources.
The FDA cautioned about the significance of having a system that reliably generates water fit for pharmaceutical use and stated that the company has not qualified its water system. In order to monitor whether the water is suitable for production, the company was required to create a remediation plan for the water system that includes total microbiological count limitations.
A thorough evaluation of the design and control of manufacturing operations, a review of all microbiological hazards, a thorough risk assessment addressing the risks associated with distributing over-the-counter drug products with potentially objectionable contamination, and investigations into all product batches with possible microbial contamination were all requested from Colgate-Palmolive/Tom’s of Maine.
In total, the business had 15 days to address the infractions and outline any necessary repair activities.
Tom’s is dedicated to creating natural goods that are safe and effective for our customers and to upholding their faith in our brand, the firm stated in a statement provided to NBC News.
“We have always tested finished goods before they leave our control, and we remain fully confident in the safety and quality of the toothpaste we make.”
The statement went on: “We have also hired water experts to assess our systems at Sanford, put in place extra measures to guarantee adherence to FDA regulations, and our water testing reveals no problems. As part of an ongoing, major overhaul to the water system at the Sanford facility, we are also undertaking capital expenditures.
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