FDA给GSK北美的疫苗工厂发出警告信

胜利者

FDA Issues Warning Letter to GSK Biologicals
Jun 26, 2014      

         

                                                                                                                            FDA issued a warning letter to GlaxoSmithKline Biologicals (GSK), North America on June 12, 2014 for deviations from cCGMP requirements found during an inspection from Mar. 31 to Apr. 9, 2014 of its influenza vaccine manufacturing facility in Quebec. GSK is making progress in addressing FDA's concerns and is working to meet supply commitments, the company said in a press release.
Problems observed included failure to assure that appropriate written procedures designed to prevent microbiological contamination of drug products are established and followed, such as validation of all aseptic and sterilization processes. FDA also observed deviations in manufacture of intermediates, including inadequate controls for the purified water system and for manufacturing processes. FDA noted that controls are inadequate to prevent bioburden and endotoxin excursions.
FDA acknowledged the company's commitments of corrective and preventive actions. FDA said that GSK had not provided sufficient detail, however, and the agency requested a meeting with senior management.

紫苏叶

@一沙一叶 这个移去你哪里？

紫苏叶

@一沙一叶 你来鉴定鉴定

一沙一叶

紫苏叶 发表于 2014-7-2 15:26
@一沙一叶 这个移去你哪里？

谢谢谢谢。