It was a wake-up call for Western regulators about the potential dangers of China's rise to prominence in API production when a blood thinner made with tainted crude heparin from there was tied to the deaths of dozens of dialysis patients in the U.S. Potentially tainted heparin from China has again been ferreted out, this time in France.
According to a recent report filed by the European Medicines Agency (EMA), an inspection of Dongying Tiandong Pharmaceutical in Dongying City, Shandong Province, by French regulators uncovered data suggesting the drugmaker has manipulated tests of crude heparin supplies that had showed the presence of ruminant DNA. It said that there was no evidence that the samples used to do retesting came from the same batches that showed the ruminant.
Regulators said that a "Misunderstanding of the basic GMP principles for handling of out of specification (OOS) results and deviations," resulted in 7 batches of crude heparin received in 2014 and 2015 being used for making finished APIs without ever being investigated for out-of-specification potency. The inspectors, in fact, found a host of problems with the drug company's testing procedures.
The company was issued a statement of noncompliance by France, which also recommended that its EU GMP certificate be revoked and that EU members consider a recall of all of its products in their countries.
The FDA in 2014 took similar actions against China's Beijing Shunxin Meihua Bio-technical, putting it on its import alert list and issuing a warning letter. In that case, the FDA said the company appeared to be getting some of its raw materials from a supplier who is on an FDA watch list of suspect companies that don't carefully monitor the source of their materials. They were unable to do a thorough investigation because the company "repeatedly" refused to let inspectors into the production area or to review records.
FDA rules require heparin be manufactured only from pig intestines because when "ruminant" animals like cattle are used, there is a chance the raw material could be contaminated with bovine spongiform encephalopathy (BSE) or oversulfated chondroitin sulfate (OSCS), a cheap filler product that saves money but can be deadly to patients. In 2008, heparin contaminated with OSCS was tied to the deaths of 80 patients in the U.S.
- access the report here