he next time that employees at Xiamen Origin Biotech want to lie to regulators about what they are doing, they may want to make sure that the doors to nearby rooms are closed.
During an inspection last January of its facilities in the southeastern Chinese province of Fujian, an employee told a US Food and Drug Administration inspector that the company did not keep any drugs on location. But while they reviewed company operations in a conference room, the inspector happened to notice that an adjacent room was being used to warehouse relabeled medicines.
The same Xiamen employee also thought nothing of telling the inspector that the company had stopped relabeling drugs in January 2015. But during the inspection, the FDA staffer reviewed a list of exported drugs that showed Xiamen had distributed them until January 2016.
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These were was just a few of several troubling violations, according to a July 19 warning letter that the agency sent to the company. And while these infractions should not be used as evidence to indict all Chinese suppliers, the problems underscore the challenges in dealing with manufacturers in a country where adherence to regulations can appear spotty, at best.
These transgressions explain, by the way, why the FDA instituted a so-called import alert — or ban — two months ago on shipments of Xiamen products to the US. The company could not be reached for comment.
Pharmaceutical and ingredients manufacturers in China and India have come under intense scrutiny in recent years due to a series of disturbing events. In 2008, for instance, 246 deaths in the United States were linked to a fake ingredient from China that was found in the blood thinner heparin. China is now the world’s largest supplier of active pharmaceutical ingredients.
In India, Ranbaxy Laboratories, which was one of the largest suppliers of generic drugs to the US, paid $500 million in fines and restitution to US authorities as part of a settlement that included pleading guilty to charges of violating drug safety laws. These episodes have raised widespread concerns about quality control. To crack down, the FDA has moved to hire additional inspectors in both countries.
Congress, however, has been impatient. Last December, members of the House Energy and Commerce Committee asked the Government Accountability Office to assess the progress the FDA has made inspecting foreign facilities since the agency undertook a new “risk-based” approach in 2010.
Meanwhile, the flow of FDA warning letters about companies based in these countries receives added attention, sometimes deservedly so. Xiamen, for instance, also lied to its customers, according to the FDA letter. The company falsified and omitted information on certificates of analysis, or CoA, which are supposed to verify the veracity of its products.
The agency cited one instance in which Xiamen fabricated the name of an employee to sign off on the certificates sent to customers. The company also omitted the name of its original ingredients supplier, but did not include a copy of the certificate. Moreover, Xiamen listed an incorrect, later expiration date on its certificate.
This may sound like insider chatter, but the FDA makes clear why such behavior is a serious problem: “Regulators and customers rely on CoA to provide accurate information regarding drug quality and pedigree. Omitting and falsifying information on CoA compromises supply chain accountability and traceability and may put consumers at risk.”
But there was more. The company also failed to establish a system for managing the quality of its medicines. More specifically, Xiamen did not have written procedures in place to qualify suppliers, run samples, retain documents or employee training. An FDA inspector found dirty warehouse spaces and spotted a rodent in the room adjacent to the warehouse.