Scholar Rock Holding Corp和Novo Nordisk近日获悉，美国食品药品监督管理局(FDA)向Catalent Indiana发出483表格后，已将该设施的检查分类确定为OAI（需要官方行动指示）级别。
这一分类表明FDA在检查过程中发现了需要采取监管措施的问题。OAI级别是FDA检查分类中较为严重的等级，通常意味着相关设施需要采取纠正措施来解决发现的缺陷。
Scholar Rock Holding Corp和Novo Nordisk近日获悉，美国食品药品监督管理局(FDA)向Catalent Indiana发出483表格后，已将该设施的检查分类确定为OAI（需要官方行动指示）级别。
这一分类表明FDA在检查过程中发现了需要采取监管措施的问题。OAI级别是FDA检查分类中较为严重的等级，通常意味着相关设施需要采取纠正措施来解决发现的缺陷。
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