2021年FDA对Thermo Fisher Scientific的格林维尔工厂进行检查时发现了17个缺陷,包括不充分的杀菌程序. 2021 FDA inspections at Thermo Fisher Scientific's Greenville plant identified 17 deficiencies, including inadequate sterilization procedures.
美国主要合同制药厂商Thermo Fisher Scientific的格林维尔工厂在过去十年中面临多起违法行为, Thermo Fisher Scientific's Greenville plant, a major U.S. contract drug manufacturer, has faced multiple regulatory violations over the past decade, particularly concerning contamination and quality control. 最近的 FDA 检查发现了 17 项缺陷，包括消毒程序不足，但尚未报告对患者的伤害。 Recent FDA inspections identified 17 deficiencies, including inadequate sterilization procedures, but no patient harm has been reported. 尽管这些问题正在得到解决,但专家们仍然关注该设施的制造做法,因为它在生产关键药物方面的作用。 Despite these issues being resolved, experts remain concerned about the facility's manufacturing practices, given its role in producing critical medications.