The Food and Drug Administration (FDA) is to inspect vaccine maker Adimmune Corp (國光生技), following a whistle-blower report of an alleged mouse infestation, Minister of Health and Welfare Chiu Tai-yuan (邱泰源) said today.
Chiu faced questions from reporters about the company prior to a meeting at the Legislative Yuan’s Social Welfare and Environmental Hygiene Committee.
The Chinese-language Mirror Media magazine earlier today reported that an employee whistle-blower on Adimmune's research and development team said the firm in July last year kept 120 white mice in the laboratory for three days, leading to their urine, feces and hair contaminating the area and potentially affecting vaccines.
Photo courtesy of Adimmune Corp
The employee also alleged that their supervisor did not report the issue to their superiors or seek to disinfect the laboratory, increasing vaccine contamination risks, the magazine reported.
If Adimmune is found to have breached good manufacturing practices (GMP), it could face fines of NT$30,000 to NT$2 million (US$922 to US$61,474), Chiu said.
FDA and ministry personnel would conduct an inspection to determine if the Pharmaceutical Affairs Act (藥事法) or Pharmaceutical GMP Regulations (藥物優良製造準則) were breached, Chiu said.
Vaccines go through a strict process of 11 quality control checkpoints during manufacturing and prior to becoming publicly available, Chiu said.
“Please rest assured about [vaccine] quality,” Chiu added.
Any results from the investigation would be announced as soon as possible, he said.
Adimmune said in a statement 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.
All animals at the lab were transported to a specialized company facility in Nantou County after the three days, and none of them were used in any subsequent vaccine-related experiments or testing, the company said.
Responding to a planned protest against a loosened interpretation of traditional Chinese medicine shops, Chiu said that traditional Chinese medicine is an important part of Taiwan’s cultural and food heritage, and should be encouraged.
Pharmacist associations are planning a demonstration on May 4 on Taipei’s Ketagalan Boulevard to protest a new interpretation from the ministry regarding regulations for traditional Chinese medicine shops.
The associations argue that the loosened restrictions allow “virtually anyone” to sell Chinese medicine, including those without professional knowledge.
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