While the FDA has repeatedly run into resistance to beef up its inspectors in China, the European Medicines Agency (EMA) has regularly sidelined plants there. It does this by sharing inspection results from each EU country with all of its members.
The most recent Chinese ingredient maker to be cited is Chengdu Okay Pharmaceutical in Qionglai, Sichuan Province, which was inspected last year by regulators from Poland, who said they were acting at the request of an API importer in their country.
What they found was a plant that was not meeting standards in manufacturing, quality control and data integrity. In fact, they tallied 21 deficiencies, of which 5 rose to the critical mark and 10 others were classified as major. They said the plant was not properly calculating impurities in the Diosmin manufactured there. Testing data had been overwritten and the company had no protections to prevent unauthorized employees from getting into and changing test results in its computerized equipment. The inspectors reported that "Some data of HVAC system qualification had been falsified."
Last month, the EMA posted the inspection results from a French inspection of Shaoxing Pharmaceutical plant in the Paojiang Industrial Zone. Among other problems, inspectors suspected the company had falsified the source of its API, thiamphenicol, and released product without traceability of testing measures. Similar kinds of issues were cited by Italian regulators last summer, when inspectors recommended bans for two plants in China and one in India.
The FDA has also been writing up plants in China including a ban, followed by a warning letter for Chan Yat Hing Medicine Factory in Hong Kong and the same for a Zhejiang Hisun Pharmaceutical plant in Taizhou City, although it last week revised its ban on the Hisun plant because of a shortage of an API needed for a chemo drug in the U.S. The agency last fall also issued a Form 483 to a Pfizer ($PFE) plant in Dalian, where employees were keeping two sets of manufacturing records.
In the case of the FDA, it would like to bolster its inspection staff stationed in China so that it can expand oversight there. But China has made that effort difficult by just not issuing visas for the people the FDA hires.
- access the report here