The agency is requiring Tom's to submit several documents, including assessments and remediation plans for its operations, contamination hazards, testing methods and more.
Personal care brand Tom's of Maine received a warning from the Food and Drug Administration earlier this month after the agency found disease-causing bacteria and mold-like and powdery substances in their products and facilities.
The FDA said despite the results of microbial tests it conducted, Tom's continued to distribute merchandise based on the test results of final products, but did not investigate the quality of water used in the process.was due to a lab error, according to the FDA. Though, the agency said there is no evidence of that.Tom's said the black substance was located in an area that was hard-to-reach and prone to moisture, but that it has since thoroughly been cleaned.
The FDA also said Tom's failed to investigate hundreds of product complaints regarding odor, color and taste because they were not indicative of a trend. According to the FDA, Tom's responded by saying it handles complaints with a"risk-based approach," and that individual complaints are not enough to deem a product inadequate.
The agency is requiring Tom's to submit several documents, including assessments and remediation plans for its operations, contamination hazards, testing methods, cleaning procedures and more.Respiratory illness on the rise: Doctors urge vigilance for whooping cough, walking pneumonia
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