70374_zh-TW

liliconcom

下載FDA 483（現場檢查）數據庫

 

 

引文數據以“簡單”的形式提供，以訪問直接從FDA的電子檢查工具中提取的電子表格。 有警告和注意事項鄰接數據的完整性： 每個記錄都不包括在內 ，不包括手工記錄，這些可能只是初步結果，而不是最終形式等。

 

數據來自此頁面： https://www.fda.gov/ICECI/Inspections/ucm250720.htm

 

表格1。 數據字典

中心名稱	計劃領域
引用ID	引用ID是每個引用的唯一標識符
CFR參考編號	“聯邦法規”引用了引文
簡短的介紹	簡短或類別類型說明
詳細描述	詳細描述輸入FDA表格483
頻率	在本財政年度中，中心計劃領域483使用了引用次數
年	表格年份的衍生期限

 

 

 

names default to here(1);

dates = {"2006", "2007", "2008", "2009", "2010", "2011", "2012", "2013", "2014", "2015", "2016", "2017"}; 

pages = {"https://www.fda.gov/downloads/ICECI/Inspections/UCM255566.xls",
"https://www.fda.gov/downloads/ICECI/Inspections/UCM255565.xls", "https://www.fda.gov/downloads/ICECI/Inspections/UCM255564.xls",
"https://www.fda.gov/downloads/ICECI/Inspections/UCM255563.xls", "https://www.fda.gov/downloads/ICECI/Inspections/UCM255562.xls",
"https://www.fda.gov/downloads/ICECI/Inspections/UCM326092.xls", "https://www.fda.gov/downloads/ICECI/Inspections/UCM326093.xls",
"https://www.fda.gov/downloads/ICECI/Inspections/UCM381532.xls", 
//note: file type changes and column headers change
"https://www.fda.gov/downloads/ICECI/Inspections/UCM423298.xlsx", "https://www.fda.gov/downloads/ICECI/Inspections/UCM481633.xlsx",
"https://www.fda.gov/downloads/ICECI/Inspections/UCM531908.xlsx", "https://www.fda.gov/downloads/ICECI/Inspections/UCM589350.xlsx"};

For( i = 1, i <= N Items( pages ), i++,
 request = New HTTP Request( URL( pages[i] ), Method( "Get" ) );
//    file = request << Download( "/Users/bywing/Byron Wingerd/Examples/FDA 483 records/"||item(-1,pages[i],"/"), replace );
 file = request << Download(
  "/Users/bywing/Byron Wingerd/Examples/FDA 483 records/" || Char( dates[i] ) || "." || Item( -1, pages[i], "." ),
  replace
 );
 If( !Is Empty( file ), 
// note this puts a copy of the file in this directory 
  dt = Open(
   file,
   Worksheets(
    {"Biologics", "Bioresearch Monitoring", "Devices", "Drugs", "Foods", "Human Tissue", "Parts 1240 & 1250", "Rad Health",
    "Vet Med"}
   ),
   Use for all sheets( 1 ),
   Concatenate Worksheets( 1 ),
   Create Concatenation Column( 1 ),
   Worksheet Settings(
    1,
    Has Column Headers( 1 ),
    Number of Rows in Headers( 1 ),
    Headers Start on Row( 1 ),
    Data Starts on Row( 2 ),
    Data Starts on Column( 1 ),
    Data Ends on Row( 0 ),
    Data Ends on Column( 0 ),
    Replicated Spanned Rows( 1 ),
    Replicated Spanned Headers( 0 ),
    Suppress Hidden Rows( 1 ),
    Suppress Hidden Columns( 1 ),
    Suppress Empty Columns( 1 ),
    Treat as Hierarchy( 0 ),
    Multiple Series Stack( 0 ),
    Import Cell Colors( 0 ),
    Limit Column Detect( 0 ),
    Column Separator String( "-" )
   )
  )
 );
// cleaning and formatting the individual tables
 Try( :Ref No << set name( "Reference Number" ) );
 Try( :Short Desc << set name( "Short Description" ) );
 Try( :Long Desc << set name( "Long Description" ) );
 Try( :Frqncy << set name( "Frequency" ) );
 Try( dt << Clear Column Selection() );
 :Center Name << Set Selected( 1 );
 dt << Delete Columns();
 Try( :Source Table << set name( "Center Name" ) );
 dt << Select Where( :Reference Number == "" & :Short Description == "" & :Long Description == "" );
 dt << delete rows();
);//end for loop

Data Table( "2006" ) << Concatenate(
 Data Table( "2007" ),
 Data Table( "2008" ),
 Data Table( "2009" ),
 Data Table( "2010" ),
 Data Table( "2011" ),
 Data Table( "2012" ),
 Data Table( "2013" ),
 Data Table( "2014" ),
 Data Table( "2015" ),
 Data Table( "2016" ),
 Data Table( "2017" ),
 Output Table( "483's 2006 to 2017" ),
 Create source column
);

For( i = 1, i <= N Items( dates ), i++,
 dtr = Expr( Data Table() );
 Insert Into( dtr, dates[i] );
 Close( Eval( dtr ), no save );
 
);

 

 

https://community.jmp.com/t5/Byron-Wingerd-s-Blog/Fantastic-Trends-in-FDA-s-483s-and-How-to-Find-Them/ba-p/70362

生命科學