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FDA Warns Drug Maker About Inadequate Quality Control

drugmaker aug21 lt

The U.S. Food and Drug Administration has issued a warning letter to Ningbo Huize Commodity Co., an over-the-counter drug manufacturer, for significant current good manufacturing practice violations, including data integrity issues.

The warning letter issued to Ningbo Huize details a failure to have adequate quality control mechanisms in place. The company provided FDA investigators multiple documents that were falsified, including the cleaning validation reports and batch production and control records for multiple drugs.

The firm also provided records showing they performed the required periodic reviews of their operation to assure quality, which they later admitted were also falsified. These CGMP violations cause all drugs manufactured by Ningbo Huize to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The company has agreed to voluntarily recall drugs. The FDA requested a response from the company within 15 working days of receipt of the letter.

"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. Helping assure the quality and safety of these products is one of our greatest responsibilities as a public health agency," said Acting FDA Commissioner Ned Sharpless, M.D.

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