The FDA has again found a lot that it doesn’t like about a Chinese drugmaker. The agency has followed up an import alert against Chan Yat Hing Medicine Factory’s drugs and cosmetic products with a warning letter.
The FDA warning letter, posted to the FDA website today, follows a site visit to the Hong Kong facility last July where inspectors found that Chan Yat Hing was not meeting any of the usual protocols for producing drugs for the U.S. markets.
The letter says the plant has no procedures in place for its quality control unit to review out-of-specification results or check into customer complaints. It said it had released products to the US. despite the fact that it had failed to test finished batches for the identity and strength of active ingredients, failed to ensure the identity of components, and has no data to demonstrate that drug’s will meet their stated shelf life.
The FDA in December put the plant on its import alert list, banning not only its drug products, but also “all drug products declared as cosmetic products.” The alert noted that the company has a history of importing some drugs like its arthritis pain relieving cream, as cosmetics.
The warning letter is just the most recent action taken by Western regulators against a host of Chinese drugmakers. Last week, the FDA published a warning letter it sent to Zhejiang Hisun Pharmaceutical plant in Taizhou City, in which it noted systemic data manipulation across your facility.” That warning letter followed a ban of the facility in September. Zhejiang Hisun has a joint venture to make products for Pfizer ($PFE), but a spokesman for the JV said last week none of the JV’s products are affected by the import alert. The warning letters come after the European Medicines Agency (EMA) recently posted its own document outlining problems at a Shaoxing Pharmaceuticals plant in the Zhejiang, China.
January 19, 2016 | By Eric Palmer