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Human Genome Sciences, Inc. - Form 483, 2023-12-11
$289 - Available for instant download
Issued On: December, 2023
Inspection Type: FDA 483
Site Name: Human Genome Sciences, Inc. [Rockville / United States of America]
Institute for Human Reproduction (IHR), SC - Form 483, 2023-10-25
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: Institute for Human Reproduction (IHR), SC [Chicago / United States of America]
UMAY TRADE CO LLC - Form 483, 2023-06-16
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: UMAY TRADE CO LLC [Miami / United States of America]
Dipenkumar Modi, M.D. - Form 483, 2023-04-12
$289 - Available for instant download
Issued On: April, 2023
Inspection Type: FDA 483
Site Name: Dipenkumar Modi, M.D. [Detroit / United States of America]
Banco De Sangre Humacao, Inc. - Form 483, 2022-07-21
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: Banco De Sangre Humacao, Inc. [Humacao / United States of America]
Shire Human Genetic Therapies, Inc. - Form 483, 2022-04-22
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Shire Human Genetic Therapies, Inc. [Lexington / United States of America]
Shire Human Genetic Therapies, Inc. - Form 483, 2022-03-23
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Shire Human Genetic Therapies, Inc. [Lexington / United States of America]
Human Biosciences, Inc. - Form 483, 2022-02-15
$289 - Available for instant download
Issued On: February, 2022
Inspection Type: FDA 483
Site Name: Human Biosciences, Inc. [Gaithersburg / United States of America]
Jayant Kumar, M.D. - Form 483, 2021-05-10
$289 - Available for instant download
Issued On: May, 2021
Inspection Type: FDA 483
Site Name: Jayant Kumar, M.D. [Albuquerque / United States of America]
Strauman Manufacturing Inc. - Form 483, 2021-01-14
$289 - Available for instant download
Issued On: January, 2021
Inspection Type: FDA 483
Site Name: Strauman Manufacturing Inc. [Arlington / United States of America]
Yichang Humanwell Oral Solid Dosage Plant - Form 483, 2020-11-16
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Yichang Humanwell Oral Solid Dosage Plant [China / China]
Institute for Human Reproduction (IHR), SC - Form 483, 2020-02-25
$289 - Available for instant download
Issued On: February, 2020
Inspection Type: FDA 483
Site Name: Institute for Human Reproduction (IHR), SC [Chicago / United States of America]
Human Genome Sciences, Inc. - EIR, 2020-01-29
$1190 - Available for instant download
Issued On: January, 2020
Inspection Type: EIR
Site Name: Human Genome Sciences, Inc. [Rockville / United States of America]
Human Genome Sciences, Inc. - Form 483R, 2020-02-18
$289 - Available for instant download
Issued On: January, 2020
Inspection Type: FDA 483 Response
Site Name: Human Genome Sciences, Inc. [Rockville / United States of America]
Human Genome Sciences, Inc. - Form 483, 2020-01-29
$289 - Available for instant download
Issued On: January, 2020
Inspection Type: FDA 483
Site Name: Human Genome Sciences, Inc. [Rockville / United States of America]
Ines Guttmann-Bauman MD - Form 483, 2019-12-12
$289 - Available for instant download
Issued On: December, 2019
Inspection Type: FDA 483
Site Name: Ines Guttmann-Bauman MD [Portland / United States of America]
Umano Medical, Inc. - Form 483, 2019-12-04
$289 - Available for instant download
Issued On: December, 2019
Inspection Type: FDA 483
Site Name: Umano Medical, Inc. [L'islet / Canada]
Yichang Humanwell Oral Solid Dosage Plant - Form 483, 2019-06-28
$289 - Available for instant download
Issued On: June, 2019
Inspection Type: FDA 483
Site Name: Yichang Humanwell Oral Solid Dosage Plant [China / China]
Hubei Gedian Humanwell Pharmaceutical Co., Ltd - Form 483, 2019-06-28
$289 - Available for instant download
Issued On: June, 2019
Inspection Type: FDA 483
Site Name: Hubei Gedian Humanwell Pharmaceutical Co., Ltd [China / China]
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd - Form 483, 2019-06-14
$289 - Available for instant download
Issued On: June, 2019
Inspection Type: FDA 483
Site Name: Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd [China / China]
Puma Biotechnology, Inc. - Form 483, 2019-05-24
$289 - Available for instant download
Issued On: May, 2019
Inspection Type: FDA 483
Site Name: Puma Biotechnology, Inc. [Los Angeles / United States of America]
Human Genome Sciences, Inc. - Form 483, 2019-03-15
$289 - Available for instant download
Issued On: March, 2019
Inspection Type: FDA 483
Site Name: Human Genome Sciences, Inc. [Rockville / United States of America]
John Kumar Jain MD Inc. - Form 483, 2019-02-08
$289 - Available for instant download
Issued On: February, 2019
Inspection Type: FDA 483
Site Name: John Kumar Jain MD Inc. [Santa Monica / United States of America]
John Kumar Jain MD Inc. - Form 483R, 2019-02-27
$289 - Available for instant download
Issued On: February, 2019
Inspection Type: FDA 483 Response
Site Name: John Kumar Jain MD Inc. [Santa Monica / United States of America]
Dr. Sandeep Kumar Gupta - Form 483, 2018-08-31
$289 - Available for instant download
Issued On: August, 2018
Inspection Type: FDA 483
Site Name: Dr. Sandeep Kumar Gupta [Lucknow / India]
Lumanosity Inc - EIR, 2018-08-24
$1190 - Available for instant download
Issued On: August, 2018
Inspection Type: EIR
Site Name: Lumanosity Inc [San Diego / United States of America]
Lumanosity Inc - Form 483, 2018-08-24
$289 - Available for instant download
Issued On: August, 2018
Inspection Type: FDA 483
Site Name: Lumanosity Inc [San Diego / United States of America]
Human Subjects Research Committee - Form 483, 2018-08-23
$289 - Available for instant download
Issued On: August, 2018
Inspection Type: FDA 483
Site Name: Human Subjects Research Committee [Minneapolis / United States of America]
Human Subjects Research Committee - Form 483R, 2018-09-14
$289 - Available for instant download
Issued On: August, 2018
Inspection Type: FDA 483 Response
Site Name: Human Subjects Research Committee [Minneapolis / United States of America]
Shire Human Genetic Therapies, Inc. - Form 483, 2018-07-25
$289 - Available for instant download
Issued On: July, 2018
Inspection Type: FDA 483
Site Name: Shire Human Genetic Therapies, Inc. [Lexington / United States of America]
ASANUMA CORPORATION - Form 483, 2018-06-15
$289 - Available for instant download
Issued On: June, 2018
Inspection Type: FDA 483
Site Name: ASANUMA CORPORATION [Sagamihara / Japan]
Human Biologics of Texas - Form 483, 2018-04-19
$289 - Available for instant download
Issued On: April, 2018
Inspection Type: FDA 483
Site Name: Human Biologics of Texas [San Antonio / United States of America]
Humanoptics Ag. - Form 483, 2018-04-19
$289 - Available for instant download
Issued On: April, 2018
Inspection Type: FDA 483
Site Name: Humanoptics Ag. [Sankt Augustin / Germany]
Human Biologics of Texas - Form 483R, 2018-05-10
$289 - Available for instant download
Issued On: April, 2018
Inspection Type: FDA 483 Response
Site Name: Human Biologics of Texas [San Antonio / United States of America]
Richard Dumas - Form 483, 2018-03-29
$289 - Available for instant download
Issued On: March, 2018
Inspection Type: FDA 483
Site Name: Richard Dumas [Laval / Canada]
Richard Dumas - Form 483, 2018-03-29
$289 - Available for instant download
Issued On: March, 2018
Inspection Type: FDA 483
Site Name: Richard Dumas [Laval / Canada]
Georgia STE DEPT Human Resources IRB#1 - Form 483, 2018-03-08
$289 - Available for instant download
Issued On: March, 2018
Inspection Type: FDA 483
Site Name: Georgia STE DEPT Human Resources IRB#1 [Atlanta / United States of America]
Shire Human Genetic Therapies, Inc. - Form 483, 2018-02-01
$289 - Available for instant download
Issued On: February, 2018
Inspection Type: FDA 483
Site Name: Shire Human Genetic Therapies, Inc. [Cambridge / United States of America]
Straumann USA LLC - Form 483, 2017-07-21
$289 - Available for instant download
Issued On: July, 2017
Inspection Type: FDA 483
Site Name: Straumann USA LLC [Andover / United States of America]
Princy Kumar, M.D. - Form 483, 2017-07-17
$289 - Available for instant download
Issued On: July, 2017
Inspection Type: FDA 483
Site Name: Princy Kumar, M.D. [Washington / United States of America]
Human Biosciences, Inc. - Form 483, 2017-06-27
$289 - Available for instant download
Issued On: June, 2017
Inspection Type: FDA 483
Site Name: Human Biosciences, Inc. [Gaithersburg / United States of America]
Gerrit J. Bouma, MD - Form 483, 2017-03-10
$289 - Available for instant download
Issued On: March, 2017
Inspection Type: FDA 483
Arthur Schuman Midwest LLC - Form 483, 2017-03-08
$289 - Available for instant download
Issued On: March, 2017
Inspection Type: FDA 483
Site Name: Arthur Schuman Midwest LLC [Elgin / United States of America]
ASANUMA CORPORATION - Form 483, 2017-02-02
$289 - Available for instant download
Issued On: February, 2017
Inspection Type: FDA 483
Site Name: ASANUMA CORPORATION [Sagamihara / Japan]
Shire Human Genetic Therapies, Inc. - Form 483, 2017-01-20
$289 - Available for instant download
Issued On: January, 2017
Inspection Type: FDA 483
Site Name: Shire Human Genetic Therapies, Inc. [Lexington / United States of America]
Shire Human Genetic Therapies, Inc. - EIR, 2017-01-05
$1190 - Available for instant download
Issued On: January, 2017
Inspection Type: EIR
Site Name: Shire Human Genetic Therapies, Inc. [North Reading / United States of America]
Jiangsu Jumao Medical Equipment Co., Ltd. - Form 483, 2016-12-08
$289 - Available for instant download
Issued On: December, 2016
Inspection Type: FDA 483
Site Name: Jiangsu Jumao Medical Equipment Co., Ltd. [- / China]
Douglas R Schumacher MD - EIR, 2016-10-03
$1190 - Available for instant download
Issued On: October, 2016
Inspection Type: EIR
Site Name: Douglas R Schumacher MD [Columbus / United States of America]
Hubei Gedian Humanwell Pharmaceutical Co., Ltd - Form 483, 2016-05-13
$289 - Available for instant download
Issued On: May, 2016
Inspection Type: FDA 483
Site Name: Hubei Gedian Humanwell Pharmaceutical Co., Ltd [China / China]
Human Genome Sciences, Inc. - EIR, 2016-04-11
$1190 - Available for instant download
Issued On: April, 2016
Inspection Type: EIR
Site Name: Human Genome Sciences, Inc. [Rockville / United States of America]
Umass Memorial Medical Center Stem Cell Cryopreservation Lab - Form 483, 2015-12-11
$289 - Available for instant download
Issued On: December, 2015
Inspection Type: FDA 483
Site Name: Umass Memorial Medical Center Stem Cell Cryopreservation Lab [Worcester / United States of America]
UMASS Memorial Medical Center, Inc. - EIR, 2015-12-10
$1190 - Available for instant download
Issued On: December, 2015
Inspection Type: EIR
Site Name: UMASS Memorial Medical Center, Inc. [Worcester / United States of America]
Shreyaskumar R. Patel, MD - Form 483, 2015-09-30
$289 - Available for instant download
Issued On: September, 2015
Inspection Type: FDA 483
Site Name: Shreyaskumar R. Patel, MD [Houston / United States of America]
Shreyaskumar R. Patel, MD - EIR, 2015-09-30
$1190 - Available for instant download
Issued On: September, 2015
Inspection Type: EIR
Site Name: Shreyaskumar R. Patel, MD [Houston / United States of America]
Shire Human Genetic Therapies, Inc. - Form 483, 2015-08-14
$289 - Available for instant download
Issued On: August, 2015
Inspection Type: FDA 483
Site Name: Shire Human Genetic Therapies, Inc. [Lexington / United States of America]
Human Genome Sciences, Inc. - Form 483, 2015-07-24
$289 - Available for instant download
Issued On: July, 2015
Inspection Type: FDA 483
Site Name: Human Genome Sciences, Inc. [Rockville / United States of America]
Shreyaskumar R. Patel, MD - Form 483, 2015-04-02
$289 - Available for instant download
Issued On: April, 2015
Inspection Type: FDA 483
Site Name: Shreyaskumar R. Patel, MD [Houston / United States of America]
Emerson Hospital Human Rights Committee - Form 483R, 2014-08-04
$289 - Available for instant download
Issued On: July, 2014
Inspection Type: FDA 483 Response
Site Name: Emerson Hospital Human Rights Committee [Concord / United States of America]
Emerson Hospital Human Rights Committee - Form 483, 2014-07-24
$289 - Available for instant download
Issued On: July, 2014
Inspection Type: FDA 483
Site Name: Emerson Hospital Human Rights Committee [Concord / United States of America]
Emerson Hospital Human Rights Committee - EIR, 2014-07-24
$1190 - Available for instant download
Issued On: July, 2014
Inspection Type: EIR
Site Name: Emerson Hospital Human Rights Committee [Concord / United States of America]
Douglas R Schumacher MD - EIR, 2014-05-28
$1190 - Available for instant download
Issued On: May, 2014
Inspection Type: EIR
Site Name: Douglas R Schumacher MD [Columbus / United States of America]
Shire Human Genetic Therapies, Inc. - EIR, 2014-01-30
$1190 - Available for instant download
Issued On: January, 2014
Inspection Type: EIR
Site Name: Shire Human Genetic Therapies, Inc. [North Reading / United States of America]
HUMAN SCIENCE FOUNDATION - Form 483, 2014-01-16
$289 - Available for instant download
Issued On: January, 2014
Inspection Type: FDA 483
Site Name: HUMAN SCIENCE FOUNDATION [Gardena / United States of America]
UCSF Human Islet & Cellular Transplantation Facility - Form 483, 2013-12-10
$289 - Available for instant download
Issued On: December, 2013
Inspection Type: FDA 483
Site Name: UCSF Human Islet & Cellular Transplantation Facility [San Francisco / United States of America]
Lumasense Technologies, Inc. - Form 483, 2013-08-28
$289 - Available for instant download
Issued On: August, 2013
Inspection Type: FDA 483
Site Name: Lumasense Technologies, Inc. [Santa Clara / United States of America]
Shire Human Genetic Therapies, Inc. - Form 483, 2013-08-05
$289 - Available for instant download
Issued On: August, 2013
Inspection Type: FDA 483
Site Name: Shire Human Genetic Therapies, Inc. [Cambridge / United States of America]
Univ Of NM School Of Medicine Human Research Review Committe - Form 483, 2013-05-15
$289 - Available for instant download
Issued On: May, 2013
Inspection Type: FDA 483
Univ Of NM School Of Medicine Human Research Review Committe - Form 483R, 2013-06-06
$289 - Available for instant download
Issued On: May, 2013
Inspection Type: FDA 483 Response
Human Genome Sciences, Inc. - Form 483, 2013-04-26
$289 - Available for instant download
Issued On: April, 2013
Inspection Type: FDA 483
Site Name: Human Genome Sciences, Inc. [Rockville / United States of America]
Shire Human Genetic Therapies, Inc. - Form 483, 2013-02-26
$289 - Available for instant download
Issued On: February, 2013
Inspection Type: FDA 483
Site Name: Shire Human Genetic Therapies, Inc. [Lexington / United States of America]
Anatomical Solutions, LLC dba Rapid Trauma - Form 483, 2013-01-15
$289 - Available for instant download
Issued On: January, 2013
Inspection Type: FDA 483
Site Name: Anatomical Solutions, LLC dba Rapid Trauma [San Antonio / United States of America]
Human Biosciences, Inc. - Form 483, 2013-01-04
$289 - Available for instant download
Issued On: January, 2013
Inspection Type: FDA 483
Site Name: Human Biosciences, Inc. [Gaithersburg / United States of America]
Shire Human Genetic Therapies, Inc. - Form 483, 2012-08-31
$289 - Available for instant download
Issued On: August, 2012
Inspection Type: FDA 483
Site Name: Shire Human Genetic Therapies, Inc. [Lexington / United States of America]
University Of Washington Human Subjects Division - EIR, 2012-08-10
$1190 - Available for instant download
Issued On: August, 2012
Inspection Type: EIR
Site Name: University Of Washington Human Subjects Division [Seattle / United States of America]
Human Biologics of Texas - EIR, 2012-05-25
$1190 - Available for instant download
Issued On: May, 2012
Inspection Type: EIR
Site Name: Human Biologics of Texas [San Antonio / United States of America]
Sudhirkumar Patel, MD - Form 483R, 2012-06-06
$289 - Available for instant download
Issued On: May, 2012
Inspection Type: FDA 483 Response
Site Name: Sudhirkumar Patel, MD [Greenville / United States of America]
Sudhirkumar Patel, MD - Form 483, 2012-05-17
$289 - Available for instant download
Issued On: May, 2012
Inspection Type: FDA 483
Site Name: Sudhirkumar Patel, MD [Greenville / United States of America]
Sudhirkumar Patel, MD - EIR, 2012-05-17
$1190 - Available for instant download
Issued On: May, 2012
Inspection Type: EIR
Site Name: Sudhirkumar Patel, MD [Greenville / United States of America]
Shire Human Genetics Therapies, Inc. - Form 483, 2012-01-11
$289 - Available for instant download
Issued On: January, 2012
Inspection Type: FDA 483
Site Name: Shire Human Genetics Therapies, Inc. [Cambridge / United States of America]
Shire Human Genetic Therapies, Inc. - EIR, 2012-01-06
$1190 - Available for instant download
Issued On: January, 2012
Inspection Type: EIR
Site Name: Shire Human Genetic Therapies, Inc. [North Reading / United States of America]
Shire Human Genetic Therapies, Inc. - Form 483, 2012-01-06
$289 - Available for instant download
Issued On: January, 2012
Inspection Type: FDA 483
Site Name: Shire Human Genetic Therapies, Inc. [North Reading / United States of America]
Anil Kumar, M.D. - Form 483, 2011-11-02
$289 - Available for instant download
Issued On: November, 2011
Inspection Type: FDA 483
Site Name: Anil Kumar, M.D. [Lancaster / United States of America]
Anil Kumar, M.D. - EIR, 2011-11-02
$1190 - Available for instant download
Issued On: November, 2011
Inspection Type: EIR
Site Name: Anil Kumar, M.D. [Lancaster / United States of America]
Center for the Improvement of Human Functioning Intl IRB - Form 483, 2011-07-08
$289 - Available for instant download
Issued On: July, 2011
Inspection Type: FDA 483
Site Name: Center for the Improvement of Human Functioning Intl IRB [Wichita / United States of America]
Center for the Improvement of Human Functioning Intl IRB - EIR, 2011-07-08
$1190 - Available for instant download
Issued On: July, 2011
Inspection Type: EIR
Site Name: Center for the Improvement of Human Functioning Intl IRB [Wichita / United States of America]
Asokumar Buvanendran - EIR, 2010-11-02
$1190 - Available for instant download
Issued On: November, 2010
Inspection Type: EIR
Site Name: Asokumar Buvanendran [Chicago / United States of America]
Asokumar Buvanendran - Form 483, 2010-11-02
$289 - Available for instant download
Issued On: November, 2010
Inspection Type: FDA 483
Site Name: Asokumar Buvanendran [Chicago / United States of America]
Asokumar Buvanendran - Form 483R, 2010-11-17
$289 - Available for instant download
Issued On: November, 2010
Inspection Type: FDA 483 Response
Site Name: Asokumar Buvanendran [Chicago / United States of America]
Human Genome Sciences Inc - Form 483, 2010-09-24
$289 - Available for instant download
Issued On: October, 2010
Inspection Type: FDA 483
Site Name: Human Genome Sciences Inc [Rockville / United States of America]
Augusta University IRB- Medical College Of Georgia Human Assurance Committee - EIR, 2010-08-10
$1190 - Available for instant download
Issued On: August, 2010
Inspection Type: EIR
Lumasense Technologies, Inc. - Form 483, 2010-04-16
$289 - Available for instant download
Issued On: April, 2010
Inspection Type: FDA 483
Site Name: Lumasense Technologies, Inc. [Santa Clara / United States of America]
UCSF Human Islet & Cellular Transplantation Facility - Form 483, 2010-03-31
$289 - Available for instant download
Issued On: March, 2010
Inspection Type: FDA 483
Site Name: UCSF Human Islet & Cellular Transplantation Facility [San Francisco / United States of America]
CATALENT PR HUMACAO, INC./dba CATALENT PHARMA SOLUTIONS, LLC - Form 483, 2010-03-18
$289 - Available for instant download
Issued On: March, 2010
Inspection Type: FDA 483
Site Name: CATALENT PR HUMACAO, INC./dba CATALENT PHARMA SOLUTIONS, LLC [Humacao / United States of America]
Shire Human Genetics Therapies, Inc. - Form 483, 2010-01-07
$289 - Available for instant download
Issued On: January, 2010
Inspection Type: FDA 483
Site Name: Shire Human Genetics Therapies, Inc. [Cambridge / United States of America]
Human Genome Sciences Inc - Form 483, 2009-09-21
$289 - Available for instant download
Issued On: September, 2009
Inspection Type: FDA 483
Site Name: Human Genome Sciences Inc [Rockville / United States of America]
Human Genome Sciences Inc - Form 483, 2008-09-04
$289 - Available for instant download
Issued On: September, 2008
Inspection Type: FDA 483
Site Name: Human Genome Sciences Inc [Rockville / United States of America]
CATALENT PR HUMACAO, INC./dba CATALENT PHARMA SOLUTIONS, LLC - EIR, 2005-09-20
$1190 - Available for instant download
Issued On: September, 2005
Inspection Type: EIR
Site Name: CATALENT PR HUMACAO, INC./dba CATALENT PHARMA SOLUTIONS, LLC [Humacao / United States of America]
CATALENT PR HUMACAO, INC./dba CATALENT PHARMA SOLUTIONS, LLC - EIR, 2004-06-16
$1190 - Available for instant download
Issued On: June, 2004
Inspection Type: EIR
Site Name: CATALENT PR HUMACAO, INC./dba CATALENT PHARMA SOLUTIONS, LLC [Humacao / United States of America]
Numare Spectralab, Inc. - EIR, 2003-10-03
$1190 - Available for instant download
Issued On: October, 2003
Inspection Type: EIR
Site Name: Numare Spectralab, Inc. [Kintnersville / United States of America]
Christian Aumais, M.D. - Form 483, 2003-07-10
$289 - Available for instant download
Issued On: July, 2003
Inspection Type: FDA 483
Site Name: Christian Aumais, M.D. [Montreal / Canada]