The US Food and Drug Administration (FDA) issued the UK drug major with the warning letter on June 12 after an inspection of the facility in Ste-Foy, Quebec in March uncovered problems relating to quality control and manufacturing procedures.
The main concern is that GSK has not taken steps to prevent vaccines produced at the facility being contaminated by microbes. According to the US agency the UK drugmaker has already discarded 20 of the lots made at the plant this year as a result of “endotoxin excursions.”
Endotoxins – the proteins found in the cell walls of gram negative pathogens that can cause allergic reactions and other health problems – have been a problem at the facility since 2011 according to the FDA.
“In 2011, 24 Flulaval monovalent lots were rejected due to OOS endotoxin results,” the agency said, adding that 16 lots were discarded the following year for the same reason.
“In 2013,” the FDA continued “Flulaval monovalent lots used for process validation, had bioburden or endotoxin excursions. These lots were manufactured on the same equipment as commercial lots for release to the US.”
GSK: Making progress
In a statement sent to in-Pharmatechnologist.com GSK confirmed it received the warning letter and is “making progress addressing these concerns and we are committed to working with the agency to fully resolve all outstanding issues.”
The firm also said that, despite the problems at the facility, it will continue to produce Flulaval ahead of this winter’s influenza season.
“GSK produces influenza vaccines for the US and Canada at the Ste-Foy facility. Pending FDA approvals, GSK anticipates providing between 28 million and 33 million doses of influenza vaccine to the US for the 2014-15 flu season.”
The firm added that it “is also working with Canadian health authorities to meet GSK supply commitments for 2014-15.”
GSK normally starts shipping Flulaval at the end of July.
Publication of the FDA letter comes just a day after Texas, US-based manufacturer Kalon Biotherapeutics confirmed that one of the new plants it is building will produce flu vaccines for GSK.