FDA warns company for putting consumers at risk with drug manufacturing data integrity violations
U.S. Food and Drug Administration posted a warning letter to Ningbo Huize Commodity Co., an over-the-counter (OTC) drug manufacturer, for significant current good manufacturing practice (CGMP) 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 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 U.S. market. The company has also agreed to voluntarily recall drugs.
The FDA 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. 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.
Most manufacturers are complying with the CGMP regulations and following technical standards outlined in guidances and in meetings with stakeholders and Americans should continue to use the OTC products, like sunscreen and toothpaste, they produce. The FDA will continue to ensure that drug manufacturers around the globe meet the required standards for drug quality that American consumers expect.