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Byron_JMP

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Joined:

Apr 26, 2012

Download the FDA 483 (Site Inspections) Database

 

 

The citation data is provided in "easy" to access spreadsheets that are pulled directly from the FDA’s electronic inspections tools.  There warinings and caveats abut the completeness of the data: Every record is not included, manual records aren’t included, and these might just be preliminary results, not the final form etc.

 

The data are from this page: https://www.fda.gov/ICECI/Inspections/ucm250720.htm

 

Table 1.  Data Dictionary

Center Name

Program Area

Cite ID

Cite ID is a unique identifier for each citation

CFR Reference No.

The Code of Federal Regulations reference for the citation

Short Description

Short or category type description

Long Description

The long description is entered on to the FDA Form 483

Frequency

The number of times during the fiscal year the citation was used on a 483 for the Center Program Area

Year

Derived Term, for year of table

 

 

 

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-The...

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