Tom’s of Maine says it will remedy mold, bacteria problems found by FDA at Sanford plant
File photo / COURTESY, TOM'S OF MAINE
Tom’s of Maine is headquartered in Kennebunk and has a production facility in Sanford.
Tom’s of Maine, a manufacturer of natural oral and personal care products, says it’s working with the U.S. Food and Drug Administration to remedy contamination found in an inspection of the company's toothpaste manufacturing plant in Sanford.
Earlier this month, the company received a warning letter from the FDA summarizing the agency’s inspection of the facility at 27 Community Drive from May 7 to May 22.
The letter said inspectors found “significant violations” that included the presence of harmful bacteria in samples of water used to make some products and for rinsing equipment in cleaning processes.
The FDA said the system used to produce water for equipment cleaning and in formulating products was inadequate.
“Water is a major ingredient in many of your OTC drug products,” the FDA said. “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 agency instructed the company to provide a comprehensive remediation plan for the design, control and maintenance of the water system.
The FDA also said the company “failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair.”
The letter continued, “Our investigator observed a black mold-like substance” at the base of a hose reel, behind a water storage tank and at the base of the wall behind the tank. The substance was within one foot of stainless-steel pails and other product-contact equipment used for production.
“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 letter said.
Recovered bacteria included three strains: Pseudomonas aeruginosa, Ralstonia insidiosa and Paracoccus yeei.
Founded in 1970 and headquartered in Kennebunk, Tom’s of Maine has been a subsidiary of global consumer products maker Colgate-Palmolive Co. (NYSE: CL) since 2006 and employs 120 people. The majority of Tom's products are vegan; a few contain beehive ingredients.
Remediation plans
“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,” Tom’s of Maine said in a statement sent to Mainebiz.
“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.”
The company said it is also making capital investments as part of an ongoing, significant upgrade of the Sanford plant’s water system.
“Tom’s is committed to making safe and effective natural products for our consumers, and to maintaining the trust in our brand,” the statement said.
The FDA has instructed Tom's of Maine to provide:
- An assessment of the design and control of its manufacturing operations, with a review of all microbiological hazards;
- A risk assessment addressing hazards posed by distributing over-the-counter drug products with potentially objectionable contamination, including actions such as customer notifications and product recalls;
- Investigations into all batches with potential objectionable microbial contamination, including findings regarding the root causes of the contamination;
- A corrective and preventive action plan and status to implement routine, vigilant operations management oversight of facilities and equipment, that would ensure prompt detection of equipment and facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment and facility infrastructure and improved systems for ongoing management review;
- An independent retrospective assessment of cleaning effectiveness to evaluate the scope of cross-contamination hazards.
The company was advised to engage a consultant to assist it in meeting the requirements.
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