FDA Warns Chinese Drugmaker Xiamen Origin Biotech Over Making False Statements to Regulators

August 5, 2016
By Alex Keown, BioSpace.com Breaking News Staff

WASHINGTON – The U.S. Food and Drug Administration has a warning for Chinese company Xiamen Origin Biotech—don’t lie. A January inspection of that company’s facilities in China revealed a number of violations by the company, including a false claim that no drugs were kept on site. However, an FDA inspector saw a room that was used to warehouse relabeled medications, StatNews reported this morning. Inspectors also noted that despite being told that Xiamen Origin Biotech has ceased relabeling drugs in January 2015, one year prior to the FDA inspection, investigators “reviewed a list of exported drugs that showed Xiamen had distributed them until January 2016,” StatNews said.

Those findings caused the FDA to issue a harsh warning letter to the Chinese company outlining the problems and notifying the company it was being placed on an Import Alert list. In the letter, the FDA noted the incidents of misleading statements from employees.

“During the inspection, an employee told the investigator that there were no drugs on site. The investigator observed a room adjacent to the conference room that was being used as a warehouse for relabeled drugs,” the FDA letter said. “The same employee told the investigator that your firm stopped relabeling drugs in January, 2015. However, during the inspection, the investigator reviewed an exported drugs list that showed that your firm distributed drugs after January 2015 and into January 2016.”

The FDA recommended the Chinese company hire a consultant qualified to “evaluate your operations and assist your firm in meeting CGMP requirements.”

“Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance,” the FDA said. Xiamen Origin Biotech was given 15 days to respond to the FDA’s concerns.

The FDA concerns raised regarding practices at Xiamen Origin Biotech are just the latest issues federal regulators have regarding foreign drug labs. StatNews reported that 246 U.S. deaths were linked to fake ingredients from China found in the blood-thinning medication heparin in 2008.

The FDA has cited labs in India for several failures. In 2008, the U.S. Food and Drug Administration banned the sale of medicine from Indian drug maker Ranbaxy due to manufacturing violations. In March, the FDA issued a warning letter to Apotex over manufacturing violations at a plant in Bangalore, India. In its letter, the FDA said lab workers failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards. The FDA also said the lab workers failed to establish appropriate procedures to prevent bacteria from developing. Apotex was also forced to recall more than 65,000 bottles of blood pressure medication made at the Bangalore plant after testing discovered impurities in the medication.

These concerns have forced Congress to turn its eyes to the FDA to assess progress federal regulators have made “inspecting foreign facilities since the agency undertook a new ‘risk-based’ approach in 2010,” StatNews said.