As the incoming Trump administration weighs its approach to China and its role in the pharmaceutical supply chain, consider the case of Tianjin Darentang Jingwanhong Pharmaceutical.
The company, which bills itself as a purveyor of traditional Chinese medicines, refused to allow inspectors from the U.S. Food and Drug Administration to access records and certain key production areas, or photograph machinery during a visit to its facilities last March, according to an Oct. 30 warning letter that was posted on the agency web site this week.
Specifically, the FDA maintained that employees refused to provide complete validation reports and production records for a medicine. Instead, the employees provided translated copies of the documents, but these were “heavily” redacted, and they explained that company management required them to protect the information in the records.
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