Tianjin Darentang Jingwanhong Pharmaceuticals rejected the FDA

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 one supplier of traditional Chinese medicine, refused to allow inspectors from the US Food and Drug Administration to access records and some key production areas, or photograph machinery during a visit to its facilities last March, according to an Oct. 30 filing. warning letter which was published on the agency’s website this week.

Specifically, the FDA alleged that employees refused to provide complete validation reports and production records for a drug. Instead, the employees provided translated copies of the documents, but these were “heavily” redacted and they explained that management required them to protect the information in the records.

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