The FDA hit Chinese drugmaker Shandong Vianor Biotech with a warning letter and placed the company on an import alert following an inspection that uncovered falsified test results and during which officials barred access to an investigator.
During the May inspection, Vianor Biotech management admitted to regulatory inspectors that they falsified analytical test results used to release a lot of its products to the U.S. Additionally, the agency said the company reported a batch of one of its products was within specification in its certificate of analysis (CoA) despite lab analysis that indicated the product was subpotent.
"When questioned about why the CoA reported passing results even though the batch actually failed, your quality unit manager stated, 'I made a mistake,'" the FDA said in a letter to Vianor Biotech that was posted on the agency’s website Tuesday.
The inspection also found "rusted and corroded screws, fluid and debris and metallic mesh material on the product contact surfaces," at the plant located in Linyi, China.
During the inspection, the agency said, company officials prevented an investigator from entering a room identified as a laboratory. Later, when allowed to enter the room, the investigator found there was no equipment. The company then said the laboratory was actually offsite, and that “it was not a convenient time” for the investigator to inspect those premises.
The FDA placed Vianor Biotech on an import alert in August.