Chinese drugmaker warned by FDA for faking lab records
- Drugmaker Shandong Vianor Biotech Co., Ltd. has become the latest Chinese manufacturer to be slapped with a warning letter from the Food and Drug Administration for violations of current good manufacturing practices.
- The compliance shortfalls laid out by the warning letter are noteworthy, ranging from faking analytical test results to improperly certifying subpotent drugs.
- Shandong Vianor has already been placed on the FDA's import alert. Until the company corrects the violations flagged in the letter, the regulator can withhold approval of any drug products that list Shandong as a manufacturer.
Drug manufacturing in China is a growth industry. Already a major supplier of active pharmaceutical ingredients , the Chinese pharmaceutical industry has begun to climb the value chain, producing more finished goods and investing in drug development.
This growth, particularly where exported drugs and APIs are concerned, is dependent on trust. In order to preserve this trust, manufacturers need to maintain good manufacturing practices to keep in good standing with the FDA.
Increased oversight, however, has meant closer scrutiny of the production facilities, in China and in other foreign export markets like India. This past year, 26 Chinese and Indian drugmakers have been flagged for GMP violations, many for issues like lackluster quality control or failure to properly maintain sanitary conditions.
Shandong Vianor was inspected by the FDA from May 8 to 10, 2017, and responded to the FDA two weeks later. The agency didn't find its response satisfactory however, noting that it didn't include a review of the impact past GMP deficiencies had on products already shipped to the U.S.
During the inspection, the company acknowledged that it had falsified analytical test results used to support the release of drugs. Further, when the FDA crosschecked between a laboratory analysis showing a drug lot had failed and the certificate of analysis showing it was actually within specification, the quality unit manager replied nonchalantly, "I made a mistake."
More troublesome for the FDA inspector, however, was the company's efforts to bar access to a room initially identified as a laboratory. When Shandong Vianor staff finally relented, the inspector found no equipment in the room, which Shandong explained as due to the fact that the laboratory was actually off site. The FDA's agent was unable to visit the off site facility, though, as it was not a "convenient time."
- Food and Drug Administration Warning letter
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