An inspection 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.
Wednesday, November 20, 2024 11:47AMAn 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.
"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 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."
"It is essential that your facility is in a good state of repair and sanitary conditions are maintained to protect drug products from potential routes of contamination," the FDA said.
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