Chinese API maker cited with second FDA warning letter

The FDA may be having difficulty getting inspectors stationed in China, but that has not stopped it from issuing warning letters to drug and ingredient makers there who have issues. The agency posted a second warning letter today for API maker Yunnan Hande Bio-Tech, which was previously cited in 2010.

The warning letter said that during an inspection at its site in Yunnan Province, an employee acknowledged altering testing data on an API batch and then using results from that batch to validate product previously manufactured.

The finding was an issue on multiple levels, the warning letter says. Not only does it put into doubt the validity of testing for all of the company's products, but the FDA pointed out that it violates GMP standards on safeguarding computerized equipment from unauthorized use. It also means the quality control department is not meeting its responsibilities to see that all products are properly tested.

The FDA acknowledged that the company is buying some new infrared (IR) spectrometer equipment that would have audit trails, so that the company, and inspectors, could see if data has been changed or deleted. But the FDA said that the company still needs a plan that insures controls on equipment are not breached. And it spanked the company for not investigating how widespread the problem was at the plant and what products may have been affected.

The FDA noted similar testing issues, including inadequate equipment and testing that was done in an area that did not have temperature controls, in the warning letter that it issued to Yunnan Hande Bio-Tech in 2010. It also criticized the company for reusing old test batches without making sure they met quality standards before they were reused in product that put on the market. That warning letter, which was closed out in 2011, also cited testing issues that had been observed as far back as 2004.

China is the go-to country for low-cost APIs and provides the bulk of the ingredients used in drugs worldwide. The FDA has been trying for several years to expand its staff in China to more than 30 drug and food inspectors from the dozen employees it has in-country now. But China has stymied those attempts by delaying visas. Former FDA Commissioner Margaret Hamburg made that issue one that she discussed with government officials during a trip to China in November. She said at the time that progress was being made.

- here's the warning letter

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