OTC drug manufacturer receives warning letter for data integrity issues

The US Food and Drug Administration (FDA) has sent a warning letter to Ningbo Huize Commodity Co for current good manufacturing practice (cGMP) violations, including data integrity issues.

“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, MD.

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 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 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.