所以，在2021年9月22日到27日之间的某一天，FDA不再使用Inspection Classification Database Search来检索检查数据了。1.2 Compliance Dashboards 链接：https://datadashboard.fda.gov/ora/cd/inspections.htm Inspections的页面内容及检查数据检索介绍 A. 页面内容：Important Notes：所以，Pre-approval inspections（...
首先,如果您作为利益相关方,可以通过信息公开法案向FDA申请,登录FDA官网后,按照相关路径找到inspection observations,下载EXCEL表格或选定年份查看统计表及分类,从而找到缺陷清单排名。其次,也可以利用一些专业的查询工具,比如博普智库的483查询工具,它汇集了FDA官方公布的483检查信息,并做了可视化的图表分析,方便快速检索。另...
1、检查数据查询 1.1 Inspection Classification Database Search 2021年9月22日小编通过Inspection Classification Database Search检索过检查数据,但是,2021年9月27日,小编在FDA网站上搜索不到Inspection Cla…
List of Active Pharmaceutical Ingredient (API) FDA 483 Inspections & Observations database available on PharmaCompass.com.
The FDA makes published 483s available through itsCDER FOIA Electronic Reading RoomandORA FOIA Electronic Reading Room. The FDA also offers theFDA Inspection Observations page, which supplies statistics on 483s that the agency has issued using automation, but not those that were manually prepared. ...
INSPECTION & reviewThe article reviews the basics, form 483s issued by Food and Drug Administration's (FDA's) Office of Regulatory Affairs (ORA) for field activities such as site inspections and enforcement and also focuses on FDA's Inspection Classification Database, as part of a transparency...
检查后,FDA将确定评估区域是否符合适用的法律和法规。FDA 和检验分类数据库(Inspection Classification Database)将每个项目区域的检验划分为以下三个分类: 没有指示采取行动 (NAI, No Action Indicated):在检查期间未发现任何不当的情况或做法(或者发现的情况不能被证明需要采取进一步监管...
When a raw material is scanned against a pick list, the container disappears from the SAP database. During the inspection, we challenged container locations of several raw materials, which returned the result “does not exist” in...
This store provides on-demand, a la carte access to FDA 483s, 483Rs, and EIRs—simply search by document, investigator, or site name, add to your cart, and proceed to checkout. ImmunoGen, Inc. - EIR Document Type EIR Inspection Duration ...
相关信息也可通过InspectionDatabase查询,为bioresearch monitoring检查项下内容。 4、FDA Debarment List 在NDA或ANDA的药物开发、批准过程中,触犯联邦法规而犯下重罪的公司或者人员名单。即黑名单。从本list中,可查询到黑名单的生效日期以及持续时间,在规定时间内,黑名单中人员或公司不能加入制药行业。