The FDA has savaged a Chinese API maker in a warning letter for a long list of violations, including hiding questionable products, lying to inspectors about products made at the Beijing plant and systemic data manipulation.
The warning letter issued Oct. 19 to Beijing Taiyang Pharmaceutical, and posted today, gives the company an action plan for comprehensive improvements that the FDA says will be required of it before it can free itself of an FDA ban imposed on the plant last spring.
The warning letter indicates the inspection last year started out badly and got worse. The letter says that when FDA inspectors first visited the plant in November 2015, they could see through a window of a warehouse numerous drums bearing the company’s label. But employees refused to let inspectors in that day and didn’t have a “reasonable explanation” for why. When inspectors returned the next day, many of the drums had been removed, but the company had no explanation of why they were gone.
The company also was slammed for “systemic data manipulation” at the facility. Employees repeated batch tests until getting acceptable results and deleted from computers those results that didn’t measure up. They didn’t investigate out-of-spec data the the company and the company then “relied on these falsified and manipulated test results to support batch release and stability data,” the letter says.
Plant officials also said the company had discontinued manufacturing a certain API in September 2015, but then inspectors found batch data in November about that API. There was missing and backdated data for at least 40 batches, the FDA said.
This is just the latest in what has become a steady stream of Chinese drugmakers to be issued warning letters after the FDA upped is presence in China. Last month it issued a warning letter to Yangzhou Hengyuan Daily Chemical Plastic in Yangzhou for many of the same problems. China accounts for half global API market and saw its exports of pharma products to the U.S. market increase 4% last year despite ongoing manufacturing problems.
- read the warning letter
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