June 24, 2014 — ID Biomedical Corporation, a Canadian drug-maker and a subsidiary of GlaxoSmithKline, has received a Warning Letter from the U.S. Food and Drug Administration (FDA) over concern about bacterial contamination in the flu vaccine Flulaval and other products.
The warnings stem from inspections between March 31 and April 9, 2014. Most of the allegations involve problems with quality control that could lead to bacterial contamination of medicines. Federal law requires that sterile medicines undergo specific validation and bioburden testing before they are allowed on the market.
The primary concern stemmed from the facility’s purified water system, which was inadequate to prevent bacterial contamination. The FDA reviewed records indicating that bacteria was found in the water system on several occasions dating back to 2011, but ID Biomedical failed to set a schedule for disinfecting the system.
The FDA also found specific problems with the Flulaval flu vaccine. The vaccine is supposed to contain only inactivated flu virus, but documents revealed instances in which ID Biomedical could not confirm that the virus was actually inactivated. This problem could potentially lead to an infection or other injury.
According to the Warning Letter:
“The deficiencies … are an indication of your quality control unit not fulfilling its responsibility to assure the identity, strength, quality, and purity of your licensed biological drug product and intermediates.”
The FDA has asked ID Biomedical and GlaxoSmithKline to review their manufacturing operations to ensure their medicines meet federal safety and sterility requirements. Regulators have requested a meeting with the company’s senior management to discuss the issues cited in the letter.
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