CNN — An inspection this year of a Tom’s of Maine’s facility in Sanford, Maine, turned up several violations, including bacteria in water used to make toothpaste, bacterial growth in another type of toothpaste and “a black mold-like substance” near manufacturing equipment, according to a warning letter from the US Food and Drug Administration to the CEO of the company’s parent firm.
Bottles of CVS Health cold and flu medicine containing phenylephrine is displayed for sale in a CVS Pharmacy store in Hawthorne, California on September 12, 2023.
The letter, which is dated November 5, outlines “significant violations” including the discovery of Pseudomonas aeruginosa – a strain of bacteria that can infect the lungs and blood and can be resistant to medications to treat it – in water used to rinse equipment and to manufacture the brand’s Tom’s Simply White Clean Mint Paste.
The FDA also found that Tom’s of Maine “failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair.”
Ralstonia insidiosa bacteria were also found in the water by Tom’s of Maine during testing.
Another bacteria that can cause human infections, gram-negative cocco-bacilli Paracoccus yeei, was found in a batch of Wicked Cool! Anticavity Toothpaste, according to the FDA.
“Water is a major ingredient in many of your OTC drug products. 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 letter says.
The agency requested additional documentation of the company’s manufacturing operations, “with a detailed and thorough review of all microbiological hazards” and evidence of test methods and results …
