Two Chinese firms get warning letters | Chemical & Engineering News
Volume 94 Issue 28 | p. 14 | Concentrates
Issue Date: July 11, 2016

Two Chinese firms get warning letters

Department: Business
Keywords: drug safety, cGMP, warning letter, China

The U.S. Food & Drug Administration has sent warning letters to two Chinese pharmaceutical chemical producers. The agency says Shanghai Desano Chemical Pharmaceutical failed to fully investigate evidence of production deviations that were revealed during analytical testing. The company also conducted “unofficial” testing and kept the data in a folder called “Test.” At Chongqing Lummy Pharmaceutical, the agency found that company analysts had falsified data generated by gas chromatographs and HPLCs by setting back their clocks. FDA also discovered that Lummy operators did not make entries in batch manufacturing records at the time operations were performed but rather completed batch records in groups.

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