Taiwanese vaccine maker Adimmune Corp could face a fine of up to NT$2 million (US$61,554) if it is found to have violated lab safety regulations, Minister of Health and Welfare Chiu Tai-yuan (邱泰源) said yesterday, after Chinese-language media said there was a rat-related sanitation breach at one of its facilities last year.
In a report published early yesterday, Mirror Media said it had learned from a whistle-blower at Adimmune that 120 lab rats had allegedly been left untended for three days in 12 cages by a vaccine developer as Typhoon Gaemi hit Taiwan in July last year.
When employees returned to work after the typhoon holiday, the lab was filled with a pungent smell from the accumulated mouse dander, urine and feces, the report said.
Photo courtesy of the Centers for Disease Control
Not only did the lab managers fail to report the incident to their superiors, but they neglected to disinfect the lab or discipline the employee responsible, possibly risking wider contamination, it said.
The Taichung-based Adimmune in a statement said that the facility where the incident occurred was a vaccine research lab, and was not in the same location as its production lines or quality control labs.
Following the typhoon holiday, all animals at the lab were transported to a specialized company facility in Nantou County, and none of them were used in any subsequent vaccine-related experiments or testing, it said.
Asked to comment on the allegations during a Legislative Yuan meeting yesterday, Chiu said the Food and Drug Administration (FDA) had sent officials to inspect the lab and find out what exactly had happened.
If the company is found to have violated Good Manufacturing Practices, it could face a fine of NT $30,000 to NT$2 million under the Pharmaceutical Affairs Act (藥事法), Chiu said.
Chiu also downplayed the risk of vaccine contamination, saying that finished vaccines undergo an 11-step inspection process by the FDA before they are sealed and made available to the public.
Adimmune is one of five companies authorized to manufacture or distribute flu vaccines in Taiwan, along with TTY Biopharm, Medigen Vaccine Biological Corp, and the Taiwan branches of Sanofi and GlaxoSmithKline.
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