Data Integrity Violations Found at China Facility

August 21, 2019

FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.

Significant data integrity violations were found at the Zhejiang facility of NingBo Huize Commodity Co., according to a warning letter FDA sent to the company on Aug. 2, 2019. According to FDA, during the inspection, which occurred from March 18–22, 2019, the company’s quality staff admitted to providing the agency with falsified documents.

Cleaning validation reports, batch records, and annual product reviews were falsified for the purpose of the inspection, according to FDA. In addition, the company was unable to provide the agency with records to support current good manufacturing practice (CGMP) requirements for equipment qualification, API testing, drug stability, process validation, and more.

“In your response, you provided some CGMP documents in writing. However, considering you falsified documents in the past, FDA is concerned regarding their validity. Your response is inadequate because you failed to fully review the scope of your deficiencies and provide evidence that you have comprehensively remediated your systems, and to implement procedures and programs that ensure ongoing control over your drug manufacturing operation,” FDA stated in the letter.

FDA is requesting the company provide an assessment and remediation plan for its quality unit; an independent assessment of its system for investigating deviations, discrepancies, complaints, out-of-specification results, and failures; an independent review of its material system; an independent assessment of its documentations systems; and a summary of data integrity assessments performed by a third-party consultant. The agency is also asking the company to provide an investigation into the data record inaccuracies, a risk assessment of potential effects of failures on the quality of product, and a management strategy for corrective actions and preventive actions.

“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 agency said in a statement

The agency placed the firm on Import Alert 66-40 on June 13, 2019.

Source: FDA