China, which manufactures most of the ingredients for Western products, has a reputation for having some pretty questionable manufacturing operations. Czech inspectors got a firsthand look at one plant that they said posed "extreme risks" to consumers.
According to two reports on the plant posted by the European Medicines Agency (EMA), authorities dropped by the Huanggang City facility of Hubei Hongyuan Pharmaceutical in October after the plant had been mentioned as an intermediate manufacturing site for the antibiotic metronidazole. The company acknowledged in its introduction that the site didn't follow EU GMP standards, the report says. During a walk-through, inspectors confirmed that.
They said they found a plant in a devastated state, with "huge layers of dust and product" that indicated that neither the plant nor the equipment was being cleaned or that equipment was being maintained. It was noted the situation posed "an extreme risk of cross-contamination." Additionally, almost none of the products that they saw had been labeled and there was no batch manufacturing documentation.
During the evaluation for metronidazole production, inspectors noted two dozen actual violations of EU cGMP standards, spanning the entire spectrum of manufacturing--quality assurance, documentation, supplier qualification, data integrity, out-of-specification handling, quality control, computerized system validation and change control.
Their recommendations? If countries have alternative suppliers for the ingredient, they suggest authorities order the recall any Hubei Hongyuan Pharmaceutical products and that the company be banned from shipping any new product. "Given the nature of non-compliances, assessment should include a complete retest of all imported batches of active substance," the report suggested.
Western authorities have stepped up inspections of Chinese plants, both of those owned by Chinese companies and those owned by Western drugmakers, and found problems in both cases. Earlier this month, the EMA posted a report by inspectors with France's drug regulator that noted a host of deficiencies at a Shaoxing Pharmaceutical plant in Zhejiang. This week, the FDA posted a warning letter for Chan Yat Hing, which it found was not meeting any of the usual protocols for producing drugs for the U.S. markets.
But U.K. officials last year also found issues at GlaxoSmithKline ($GSK) plant in the port city of Tianjin. The plant has since been closed after a chemical warehouse in the port blew up, doing widespread damage.
A Pfizer ($PFE) plant in Dalian received an FDA Form 483 last year after investigators found that employees were keeping two sets of books about batch testing that indicated they had used some expired ingredients in production. That inspection came two weeks after the FDA banned products coming out of a Hisun Pharma plant in Taizhou. That company is a joint venture partner with Pfizer, although the U.S. company has said none of the JV's products were included in the ban. The FDA has since issued a warning letter to Hisun.
- access the reports here