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The Food and Drug Administration ( FDA ) found concern bacteria and a " inglorious mould - like substance " while inspecting a installation that makes Tom ’s of Maine product , namely toothpaste .
One issue was that inspector found a microbe calledPseudomonas aeruginosain water sample distribution used to rinse off off equipment and to make toothpaste — specifically , Tom ’s only White Clean Mint Paste . The bacteria can cause a range of infections and is aparticular problem in health care context , in part because it canoften be resistive to antibiotics .
The FDA cited “significant violations” of regulations intended to keep the products safe for use.
Another bug , calledRalstonia insidiosa , was also found in many piddle sample . This bacterial coinage can taint humans , but itdoes so infrequently .
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In gain , Paracoccus yeeiwas find in a specific passel of Wicked Cool ! Anticavity Toothpaste . This is another microbe that infect people " opportunistically . " On therare occasion it stimulate sickness , it ’s most often run across in people with weakened resistant systems .
In addition to these water supply - tone issue , an inspector establish a black - mould - similar gist in two damp areas in the adroitness . " The black substance was within one foot of unstained - sword pail and other merchandise - middleman equipment used for OTC [ over - the - counter ] drug production , " the letter states .
In light of these and other findings , the FDA has requested an appraisal of the company ’s manufacturing surgical operation , along with a risk assessment of what could happen if any products were to be sold with " potentially objectionable contamination . " The agency has requested that Tom ’s of Maine specialize how the troupe will respond to that risk assessment and improve its water systems , readiness management and cleaning routine .
The FDA ’s inspection took place in May , and Tom ’s of Maine responded to its initial results in June . The FDA ’s latest letter declares that the ship’s company ’s June answer was " inadequate , " so the agency is calling for further action .
Tom ’s of Maine , which is owned by Colgate - Palmolive , has released the following statement to news sales outlet , admit CNN :
" We ’re working with the FDA and are remedy the issues raised in their May review of the Tom ’s fabrication plant in Sanford , Maine . We have always test finished goods before they leave our control , and we stay amply confident in the refuge and quality of the toothpaste we make . "
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" In addition , " the statement go on , " we have engaged water specialist to evaluate our system at Sanford , have go through extra guard to ensure complaisance with FDA standard , and our water testing show no issues . We are also making cap investments as part of an ongoing , significant upgrade of the Sanford plant life ’s water supply scheme . Tom ’s is attached to making safe and effective lifelike product for our consumers , and to keep the trust in our marque . "
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