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Ningbo Huize Commodity Company recently received a warning letter from the U.S. Food and Drug Administration over Current Good Manufacturing Practice (CGMP) violations.
The company is an over-the-counter drug manufacturer. The letter specifically mentioned a lack of adequate quality control mechanisms and falsification of records indicating Ningbo Huize performed quality control reviews.
“Americans deserve to have confidence in the quality of drugs the FDA regulates – from the prescription medicines they take to the over-the-counter products they use in their daily lives, like toothpaste and sunscreen,” said Acting FDA Commissioner Ned Sharpless. “Helping assure the quality and safety of these products is one of our greatest responsibilities as a public health agency. In recent years, the FDA has focused additional resources on efforts to prevent, uncover and combat data integrity lapses. We’ve focused comprehensive new efforts on these risks, both through our global inspections program as well as providing updated guidance, and to train our staff on identifying concerns related to data integrity. Today’s action shows our continued commitment in our oversight of over-the-counter drug manufacturing and protecting consumers from products that may put them at risk.”
The violations mean the products produced by the company are adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and mislabeled because they fail to include the required information and directions.
Ningbo Huize has fifteen days to respond to the letter.
