FDA warns OTC drug manufacturer for drug manufacturing data integrity violations

Company provided FDA investigators with multiple documents that were falsified.

"Americans deserve to have confidence in the quality of drugs the FDA regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives, such as toothpaste and sunscreen. 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," said Acting FDA Commissioner Ned Sharpless. "Today's (20 August 2019) action shows our continued commitment in our oversight of OTC drug manufacturing and protecting consumers from products that may put them at risk."

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 FDA also considers the adulterated products to be misbranded because the product labels did not include all the required information and directions for use. The labels of OTC medicines must comply with all requirements of the FD&C Act and applicable regulations. Following the inspection in March 2019, the FDA placed the company on import alert in June 2019 to prevent their drugs from entering the US market. The company has also agreed to voluntarily recall drugs.

The Agency requested a response from the company within 15 working days of receipt of the letter. The company is directed to inform the agency of the specific actions taken to address each of the agency's concerns. The warning letter also states that failure to correct violations may result in the FDA continuing to refuse admission of products manufactured at the company's facility.

The FDA has uncovered circumstances of drug quality data and information being inaccurate, which can mask problems and failures. Patients cannot be assured of the safety and effectiveness of their medication when data has been altered.

One critical way to help ensure product quality is to prevent data integrity lapses from the outset. Over the past two decades, the FDA has publicly outlined its expectations for the accuracy, reliability and truthfulness of all data and information collected by drug manufacturers. In 2018, the agency updated guidance for industry on ensuring data integrity and compliance with CGMP. The FDA's data integrity guidance aims to help manufacturers have the tools and systems in place to prevent adulterated products from entering the U.S. marketplace. Pharmaceutical quality can only be assured by robust quality control, which includes vigilant oversight of data integrity. This helps ensure the safety, effectiveness and quality of the drug products produced for the American public. When the agency finds manufacturers who are not complying with data integrity requirements, the FDA takes action against those manufacturers' practices and works to bring them into compliance.