FDA解除对格伦马克北卡工厂的检查担忧,允许全面恢复生产。
FDA lifts inspection concerns at Glenmark’s NC plant, allowing full production resumption.
美国FDA在2025年6月9日至17日进行检查后,给予格伦马克制药公司北卡罗来纳州蒙罗的设施"自愿行动指示" (VAI) 状态,允许公司恢复商业生产.
The U.S. FDA has given Glenmark Pharmaceuticals’ Monroe, North Carolina, facility a "Voluntary Action Indicated" (VAI) status after an inspection from June 9 to 17, 2025, allowing the company to resume commercial manufacturing.
该机构虽然查明了问题,但认为没有必要采取管制行动,在解决先前的关切事项上标出一个解决办法,并促成全面运作。
While the agency identified issues, it found no need for regulatory action, marking a resolution to prior concerns and enabling full operations.
该决定是继2023年6月以来发出警告信以及此前5次意见结案之后作出的。
The decision follows a warning letter since June 2023 and the closure of five prior observations.