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Food and Drug Administration.
should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions may include license suspension and or revocation. Canada, which licenses vaccines in this country, said it is aware of the situation and is working closely with the company and the FDA on the matter.
The agency also asked for a meeting with senior management Nike Janoski Blue Brown
Quebec plant have been rejected. market could be suspended or revoked.
FDA warns GSK over problems at Quebec flu vaccine manufacturing plant
deficiencies described . at the close of the inspection referenced above and this letter 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 letter stated.
The Nike Shoes Sb Blue letter, dated June 12, laid out a number of concerns, many related to sterility issues and microbial contamination problems at the GSK manufacturing facility in Ste. Foy, Que. The problems were identified during an FDA inspection of the plant from March 31 to April 9. regulatory agency noted that since 2011 multiple batches of flu vaccine from the Nike Sb Janoski Max Grey Pink
In a written statement GSK said the company is making progress toward addressing the FDA's concerns and is committed to working with the regulatory agency to fully resolve all outstanding issues.
It raised concerns about the purified water system at the plant and gave the company 15 working days in which to address the problems. If problems cannot be fixed within that time frame, the company must write to explain the delay.
The FDA letter said the Quebec facility deviates from current good manufacturing practice requirements, the industry standards enforced by licensing agencies.
of both GSK and the Quebec facility to discuss the identified problems and the proposed solutions.
In an emailed response to questions, the department said Canada has flu vaccine purchasing contracts with a number of other suppliers Nike Stefan Janoski Royal Blue
and can source additional vaccine from them if the need arises.
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