这个链接就是fda的warning letter database链接，点进去之后根据你要查的公司的方向进入相关的database查询...
FDA(483) 指的是：FDA 483表格(FDA 483 Form)，也称现场观察报告(Inspectional Observation)， 它是FDA...
(CAPA), customer complaints, and other documents. It is a form based business processes under a single Web-based platform which electronically can manage all processes which helps in ultimately avoid FDA 483 warning letters. Hundreds of companies worldwide rely on MasterControl to facilitate ...
Like FDA Form 483 Observations, Warning Letters can be very costly and can significantly delay time to market and consume capital in the process. However, FDA Warning Letters are more serious than Form 483 Observations because they represent an escalation of the process. As such, agency feedback...
View Csl Behring's FDA Inspection, Warning Letter, Form 483 Observation details related to GMP Quality Systems on PharmaCompass.com
Warning Letters可查询FDA开出的警告信:这里提供一个快速查询FDA开出所有警告信的方法,也可以按品种、时间等进行搜索。FDA警告信中描述的事项可能受到FDA和收信人之间的后续互动,可能会改变信中讨论的问题的监管状态,本模块提供收信人和FDA沟通以及FOAI申请的方法。
Food and Drug Administration (FDA). The Web site has announced the creation of the FDAnews Warning Letters Database, with real-time access to every FDA warning letter created since 2000, keyword searchability and weekly email alerts.EBSCO_AspBrown University Psychopharmacology Update...
1、Searchable Warning Letters Database FDA警告信查询数据库。收录了药品、烟草、食品等多个领域的警告信信息。可通过多种查询方式检索警告信、responseletter(如公开)或closeout letter信息。 2、InspectionsDatabase 本数据库收载了FDA对临床研究者、IRB(伦理审查委员会)以及生产、加工、包装或存放已上市的受FDA监管...
Receipt of anFDA 483 notice. This notice is usually answered after an FDA inspection. Numerous FDA inspections Multiple responses by the FDA indicating they aren’t satisfied with the manufacturing materials, the labels, or the marketing Not addressing adverse effects of dietary supplements, cosmetics...
警告信数据库(Warning Letters Database)[13]收录了FDA监管的所有产品的警告信信息(图3),并向公众全文公开。警告信中会明确指出企业必须进行纠正的问题,并为企业提交整改计划提供指导和时间框架。在警告信数据库中,可通过发布部门、是否发布了回复函(response letter...