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FDA issues warning to OTC drug manufacturer for lack of quality control
The FDA announced that it issued a warning letter to over-the-counter drug manufacturer Ningbo Huize Commodity Co., for multiple quality control violations and problems with data integrity.
“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,” Ned Sharpless, MD, acting FDA Commissioner, said in a press release. “Helping assure the quality and safety of these products is one of our greatest responsibilities as a public health agency.”
Ningbo Huize was issued the warning for not having the required quality control mechanisms in place and for submitting falsified documents. The company falsified reports for several products regarding cleaning validation, batch production and control records.
The company gave FDA investigators documentation that it completed quality assurance reviews and later admitted that they were also falsified.
As a result, all products manufactured by the company are considered adulterated under the Federal Food, Drug, and Cosmetic Act. In addition, the company’s sunscreen products were considered misbranded because they did not include all necessary product information and directions for use.
In June 2019, the FDA put the company on import alert to keep its drugs from entering the U.S. market.
Ningbo Huize has 15 working days to respond to let the FDA know how it will address each of concern listed in the warning letter. If the company does not respond, the FDA will continue to prevent its products from entering the country.
“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,” Sharpless said. – by Erin Michael
Disclosures: Sharpless is acting FDA commissioner.