China's Novacyl Wuxi gets FDA warning letter

The FDA has issued a warning letter to a Chinese plant that makes active pharmaceutical ingredients (APIs) for having suspect testing data after finding a failed test result in the trash and discovering the computer record of it had been overwritten. The letter comes as the agency is working to get more inspectors into the country, which has become the go-to producer of cheap APIs for the global market.

The FDA issued the warning letter to the Novacyl Wuxi Pharmaceutical plant in Wuxi, Jiangsu, following an October 2013 inspection that found a number of problems with the way the facility was keeping and tracking testing data. The letter said these problems raise questions about whether the company's products meet FDA standards. The agency was not satisfied with the fixes the drugmaker proposed and said it needed to do more to deal with the issues.

Inspectors reported finding a chromatogram for a particular API in the trash that showed a deviation from the standard. The company indicated that it was thrown away because it was already in the computer system but then couldn't produce that test result because it had been overwritten. The agency said the company was also changing integration parameters for an impurities test without documentation or justification and had only handwritten notes kept in a drawer for why the changes were made.

In addition, the FDA chided the company for not requiring separate passwords on computer equipment to protect the integrity of data and for having no written documentation for a manual integration procedure that was commonly used in the plant. The agency not only ordered Novacyl Wuxi to put together a validation plan for its lab computer systems that will include an audit trail, but to send a review of the analytical data and batch records for all of its distributed but unexpired APIs.

FDA Commissioner Margaret Hamburg--FiercePharma file photo
FDA Commissioner Margaret Hamburg

Chinese manufacturers dominate the market for cheap active pharmaceutical ingredients, but China has a spotty record of oversight for its burgeoning industry. The FDA opened an office there to do its own inspections after Chinese-made crude heparin was tied to dozens of deaths of dialysis patients in 2008. In 2013, Congress allocated the FDA extra money to expand its operations there, but China has held up visas for new inspectors. FDA Commissioner Margaret Hamburg met with top government oversight officials during a trip to China in November for an international regulator's meeting. She said at the time that the issues for getting more inspectors there were close to being worked out. The agency has said it intends to expand its office there to 34 from the 13 it has already, some to do drug inspections and some for food oversight.

- here's the warning letter