The topic of data integrity continues to be one of the "top finds" in the context of inspections.
"In recent years, the FDA has provided additional resources and focused on detecting and addressing data integrity gaps. We have made extensive efforts, both through our global inspection program and by providing updated guidance, and to train our employees to recognize dubious handling of data," said FDA Commissioner Ned Sharpless, M.D.
The warning letter to Ningbo Huize describes the following scenario:
During an FDA inspection in March 2019, the company handed over various quality control documents, which the managing director now admitted had been forged specifically for inspection. These include, for example, reports on cleaning validation and also batch records and other control documents for the company's various products. Records of the regularly required "Quality Reviews" were also falsified. These cGMP violations result in all drugs manufactured by Ningbo Huize being considered counterfeit under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Following the inspection in March 2019, the FDA imposed an import ban on the products to the United States.
The FDA states, "A critical factor in ensuring product quality is to avoid data integrity gaps from the outset. Over the past two decades, the FDA has publicly stated its expectations for the accuracy, reliability and truthfulness of all data and information collected from pharmaceutical manufacturers. In 2018, the Agency updated industry guidelines to ensure data integrity and CGMP compliance. The FDA's Data Integrity Policy aims to help manufacturers have the tools and systems they need to prevent counterfeit products from entering the U.S. market. Pharmaceutical quality can only be assured through robust quality control that includes careful monitoring of data integrity. This helps to ensure the safety, efficacy and quality of medicines manufactured for the American public."
Ningbo Huize explicitly promotes FDA-compliant manufacturing of all products on its proprietary website. The fact that this cannot be any proof of quality for the customer has now been impressively demonstrated. The call for unannounced FDA inspections - especially in China and India - will definitely become louder.