The FDA has savaged China’s Zhejiang Hisoar Pharmaceutical site in Taizhou City in a warning saying the company did not routinely do microbial testing on APIs shipped to the U.S., but did routinely delete other failed impurities tests that would have kept batches from being acceptable for sale.
The company's website claims it has produced ingredients for such companies as Novartis ($NVS), Sanofi ($SNY) and Pfizer ($PFE) but in January the FDA added Zhejiang Hisoar to its import alert list, banning all of the company's antibiotics and drugs manufactured at the plant in Taizhou.
That action followed an August 2015 inspection. The warning letter that emanated from the visit says the company has hired consultants to help it meet FDA standards but still has loads of work to do before its products will be acceptable for sale in the U.S.
The warning letter, posted by the FDA Tuesday, said that inspectors found computers were not protected to keep employees from deleting test results and that it uncovered multiple examples of analysts retesting samples until they “obtained desirable results,” then trashing the failed results. In another case, the FDA said the company acknowledged that a microbiologist documented test methods and results “when she had time,” and possibly did that by “memory.”
The inspectors said that when they asked for documents there were often delays in producing them. In one case, when investigators requested a completed microbial QC worksheet for an API, they were taken into another room where the document was said to be stored. When it was not produced after a 30-minute wait, they returned to the lab only to find a microbiologist trying to create the document.
The FDA told the company it wants a comprehensive investigation into the extent of the inaccuracies in data records and reporting, current risk assessment of the potential effects of the observed failures on to FDA expectations.
The warning letter is one in a series that the FDA has filed recently that track back to a number of inspections of Chinese drugmakers last year. They include warnings of smaller operations like Concept Products in Tianjin, China, which was cited for failing to even test its batches, and Fujian-based Xiamen Origin Biotech for essentially having no written procedures in place and falsifying certificates of analysis sent to customers. But several of the companies, like Shanghai Desano, have significant Western customers.
The problems of Chemical Pharmaceutical--which does work for GlaxoSmithKline’s ($GSK) ViiV Healthcare, and Chongqing Lummy Pharmaceutical--resulted in U.S.-based Lannett ($LCI) being told by the FDA that it was withdrawing a drug approval, an action over which Lannett has sued the FDA.
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