FDA Warns Chinese Drugmaker Over Falsified Data
Acting FDA Commissioner Ned Sharpless flagged the agency’s increased focus on data integrity violations — and a warning letter sent to a Chinese OTC drugmaker over falsified quality control documents.
Ningbo Huize Commodity in Zhejiang gave the agency’s investigator multiple falsified documents, including cleaning validation reports and batch production and control records for multiple drugs.
The firm also faked records to seem as if it performed required periodic operational reviews for quality assurance, the agency said.
These violations, along with incomplete product labels, made the firm’s manufactured OTC drugs adulterated and misbranded.