- Xiamen Origin Biotech, a Chinese API manufacturer, repeatedly misled its customers by falsifying information on certificates for its products and lied to inspectors from the Food and Drug Administration when asked about its relabeling practices, according to a warning letter recently released by the agency.
- The FDA banned imports into the U.S. from Xiamen in May following the January inspections detailed in the warning letter.
- Xiamen had no written procedures for numerous basic quality management practices but hardly helped its case when an employee lied to the FDA's inspector.
The pressure is on Chinese drug manufacturers as the FDA continues to ramp up the pressure on compliance. According to an analysis by Regulatory Focus, the regulator conducted 132 inspections of Chinese manufacturers in 2015, a tick up from the year before and nearly seven times the 19 checks carried out in 2007.
Drugmakers in both China and India have frequently been warned over problems maintaining basic sanitary standards, quality control and data manipulation.
In June, for example, both Shanghai Desano Chemical Pharmaceutical and Chongqing received FDA warning letters related to data irregularities and falsifying quality control data.
But Xiamen took things to a new level. According to the FDA's warning letter, Xiamen had no written procedures for supplier qualification, relabeling operations, sampling, product release, document retention, or training.
Furthermore, Xiamen reportedly falsified important information on the certificates of analysis issued to customers to validate drug quality. At one point, Xiamen used a fake employee name as a signatory authority on the documents and omitted copies of the original batch certificate for its drugs.
"Omitting and falsifying information on CoA compromises supply chain accountability and traceability and may put consumers at risk," the FDA said.
While the FDA inspected Xiamen's facilities, an employee told the investigator there were no drugs at the site. But the investigator could see a room next to where the meeting was being held which housed relabeled drugs.
That same inspector was told Xiamen stopped relabeling drugs in January 2015 but found a list of exported products which proved Xiamen distributed relabeled drugs throughout 2015.
All of these violations prompted the FDA to quickly place Xiamen on its import alert list, banning Xiamen products from the U.S. Until Xiamen is able to verify it has fixed the issues flagged in the letter, the FDA said the manufacturer's goods would continue to be denied entry to the U.S. market.