The FDA has sent the company a letter demanding they review their manufacturing policies after a subsidiary in Canada was found to have inadequate sanitation practices.
British pharmaceutical company, GlaxoSmithKline, has received a reprimand from the FDA over its manufacturing operations. In a letter to the company, the FDA demands that GSK do a global assessment of its subsidiaries and the practices employed in manufacturing its products, specifically flu vaccines.
The letter comes after a subsidiary in Sante-Foy, Quebec, called ID Biomedical, failed inspections over sanitation standards this April. The manufacturing process was found to fall short on practices that would prevent microbiological contaminations for products that were marketed and sold as sterile. Also found to be lacking was the water purification system, which exposed its 600 employees to further threats of contamination.
The company produces the flu vaccine, FluLaval, and is responsible for supplying the vaccine to Canada and America.
As a result of the failed inspections, the FDA has stated that it, “expects ID Biomedical and GSK to undertake a comprehensive and global assessment of all of its manufacturing operations to ensure that all products conform to FDA requirements.”
GSK has promised to respond to the FDA’s reprimand with full cooperation, saying, “We are committed to working with the agency to fully resolve all outstanding issues.”
The company further asserts, “Patient safety is our first priority and we are confident in the safety of the influenza vaccines we have provided to patients. Every batch of GSK vaccines is subject to extensive review before it is released. Vaccines that do not pass this rigorous review are discarded.”
Should its reform efforts meet approval with the FDA, GSK plans to provide 28 to 33 million flu vaccines to the U.S. alone this winter. Over half of these are expected to be produced in Quebec’s facility.
The company reminded consumers that in the last year, it has produced six new medications that have been approved by the FDA, more than any other drugmaking company.
However, this recent letter from the FDA is not the first reprimand that the company has faced recently. Various accusations of corruption have abound from China, Lebanon, Iraq, Poland and Jordan. It is also dealing with criminal charges being brought against the company by the U.K.’s Serious Fraud Office. The company recently just paid £63 million to the U.S. for similar charges. In another scandal earlier this week, the company was required to apologize for a plan that was meant to utilize unpaid interns in clinical trials.
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