美国食品药品监督管理局警告Zydus生命科学公司在古吉拉特工厂的重大制造违规行为. FDA warns Zydus Lifesciences over significant manufacturing violations at its Gujarat plant.
美国食品药品监督管理局警告Zydus Lifesciences在古吉拉特工厂的生产问题, The FDA has warned Zydus Lifesciences over manufacturing issues at its Gujarat plant, citing significant violations of good manufacturing practices. 一项检查发现,该公司未能调查毒品污染和防止微生物风险。 An inspection revealed the company's failure to investigate drug contamination and prevent microbiological risks. 美国食品和药物管理局要求制定详细的补救计划来解决这些问题,并警告说,在符合要求之前,可能会拒绝批准新药. The FDA requires a detailed remediation plan to address these issues, warning that new drug application approvals may be withheld until compliance is achieved.