GSK Biologicals Issued FDA Warning Letter for Influenza VaccineBy
GlaxoSmithKline (GSK) Biologicals has received a Warning Letter, dated June 12, 2014, from the US Food and Drug Administration (FDA) relating to an inspection by the FDA carried out from March 31, 2014 to April 9, 2014, at the company’s influenza vaccine-manufacturing facility in Ste-Foy, Quebec, Canada. In the letter, the agency raised issues related to certain quality control and manufacturing procedures and related cGMP violations at the facility for the company’s influenza vaccine, Flulaval and its intermediates.
FDA cited the company for failing to assure that appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile were established and followed, which included procedures for validation of aseptic and sterilization processes. The letter cited atypical endotoxin results and issues with microbiological control. It noted that controls for the purified water system and manufacturing controls were inadequate to prevent bioburden and endotoxin excursions. FDA also noted that from 2012 to 2014, viral inactivation of several monovalent lots could not be confirmed. FDA said the company’s investigation into repeated bioburden excursions was inadequate. FDA said it expects ID Biomedical, a subsidiary of GSK (GSK acquired the company in 2005), and GSK to undertake a comprehensive and global assessment of all of its manufacturing operations to ensure that all products conform to FDA requirements.
In a statement, GSK said: “We are making progress addressing these concerns, and we are committed to working with the agency to fully resolve all outstanding issues. 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.”
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 2014-2015 flu season. GSK is also working with Canadian health authorities to meet GSK supply commitments for 2014-2015.