The FDA has read the riot act to yet another Chinese drugmaker after finding it had been hiding batch test results that showed high peaks of out-of-spec readings. The FDA gave the drugmaker a 10-point action plan the agency wants it to follow if it expects to sell API in the U.S.
The FDA conducted its inspection of Zhejiang Medicine Co’s Xinchang Pharmaceutical Factory in Shaoxing, Zhejiang in June of 2015. The FDA in a warning letter posted today said that the employees plant routinely performed “unofficial analyses” that they they kept out of the official quality control records for its APIs.
Some of those hidden records “displayed large unknown peaks that were not reported in the official records for the same samples,” the FDA reported. And that, the agency said, could mean “the presence of unknown and uncharacterized impurities (including potential contaminants) in your drugs.”
On top of that, the inspectors found that analysts were backdating testing records and they said there were insufficient controls on computerized testing equipment to keep data from being deleted or changed.
The FDA said it wants a full investigation into the extent of the data manipulation at the facility and how it affected products shipped to the U.S. The agency suggested the drugmaker hire a third-party consultant to help in that task.
The FDA has stepped up inspections at Chinese drugmakers in the last year and posted a number of warning letters for those it has found lacking. Last week it posted a warning letter for Xiamen Origin Biotech, saying it has no written procedures for how to handle all of the basic requirements, supplier qualification, sampling, product release, training, labeling, or document retention.
- here’s the warning letter
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