GSK received a letter of warning from the FDA about conditions at its manufacturing facility at Ste-Foy, Que., where the company makes flu vaccine for the Canadian and U.S. markets.
The warning stems from an inspection of the plant conducted by FDA agents earlier this year.
The letter says the facility deviates from current good manufacturing practice requirements, the industry standards enforced by licensing agencies.
The letter raises concerns about the purified water system at the plant and other issues and gives the company 15 days in which to address the problems.
A statement from GSK says the company is making progress addressing the FDA's concerns and is committed to working with the regulatory agency to fully resolve all outstanding issues.