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Descargue la base de datos de la FDA 483 (inspecciones del sitio)

 

 

Los datos de citas se proporcionan en "fácil" acceso a hojas de cálculo que se obtienen directamente de las herramientas de inspección electrónica de la FDA.  Hay advertencias y advertencias a tope de la integridad de los datos: Cada registro no está incluido. , los registros manuales no se incluyen, y estos pueden ser solo resultados preliminares, no la forma final, etc.

 

Los datos son de esta página: https://www.fda.gov/ICECI/Inspections/ucm250720.htm

 

Tabla 1.  Diccionario de datos

Nombre del centro	Área del programa
Cite ID	Cite ID es un identificador único para cada cita
Número de referencia de CFR	El Código de Reglamentos Federales de referencia para la citación.
Breve descripción	Descripción corta o tipo de categoría
descripción larga	La descripción larga se incluye en el formulario 483 de la FDA.
Frecuencia	La cantidad de veces durante el año fiscal que se usó la citación en un 483 para el Área de Programa del Centro
Año	Plazo derivado, por año de tabla

 

 

 

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

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