FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality

Chinese API Makers Land Warning Letters For Falsified Data, Improper Testing

July 6, 2016
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The FDA is accusing two Chinese API manufacturers of doctoring laboratory results, with one cited for falsifying lab reports and the other for running both official and unofficial tests.

The first warning letter blasted Chongqing Lummy Pharmaceutical for using incomplete and falsified records to evaluate drug quality. The agency concluded that a company analyst manipulated a computerized gas chromatography system to deliver falsified readings for several API batches distributed to the U.S., the letter says.

In another incident, someone in the lab changed the date on the gas chromatography computer, making it appear that the test results had occurred seven months earlier. That person then performed five different injections for a finished API lot and subsequently deleted four of those backdated results.

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