The U.S. Food and Drug Administration has informed Colgate-Palmolive warning that a manufacturing facility that produces Tom’s of Maine toothpaste was using water that was contaminated with bacteria.
The letter noted that inspectors uncovered significant violations at the factory in Sanford, Maine. The FDA found two types of bacteria, Pseudomonas aeruginosa and Ralstonia insidiosa, in multiple water samples. The water was used to manufacture Tom’s Simply White Clean Mint Paste and to rinse equipment in the factory. The agency inspectors also found gram-negative cocco-bacilli Paracoccus yeei in a batch of Wicked Cool! Anticavity Toothpaste.
The bacteria can cause infections in the respiratory tract, lungs, and blood.
“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 FDA wrote in the letter.
In addition to the bacteria, inspectors also found a “black mold-like substance at the base of the hose reel and behind the water storage tank” and “powder residues at a stainless-steel tray” in the production facility.
Colgate-Palmolive said the company is working with the FDA to resolve the issues uncovered in the inspection.
“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,” a company spokesperson said in a statement to ABC News.
“In addition, we have engaged water specialists to evaluate our systems at Sanford, have implemented additional safeguards to ensure compliance with FDA standards, and our water testing shows no issues.”
Recent Comments