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Cambridge Isotope Laboratories, Inc. - Form 483R, 2020-12-23
$289 - Available for instant download
Issued On: December, 2020
Inspection Type: FDA 483 Response
Site Name: Cambridge Isotope Laboratories, Inc. [Tewksbury / United States of America]
Cambridge Isotope Laboratories, Inc. - Form 483, 2020-12-09
$289 - Available for instant download
Issued On: December, 2020
Inspection Type: FDA 483
Site Name: Cambridge Isotope Laboratories, Inc. [Tewksbury / United States of America]
Kadmon Corporation, LLC - Form 483, 2020-12-08
$289 - Available for instant download
Issued On: December, 2020
Inspection Type: FDA 483
Site Name: Kadmon Corporation, LLC [Cambridge / United States of America]
Andrew Blauvelt, MD, MBA - EIR, 2020-12-08
$1190 - Available for instant download
Issued On: December, 2020
Inspection Type: EIR
Site Name: Andrew Blauvelt, MD, MBA [Portland / United States of America]
Kadmon Corporation, LLC - EIR, 2020-12-08
$1190 - Available for instant download
Issued On: December, 2020
Inspection Type: EIR
Site Name: Kadmon Corporation, LLC [Cambridge / United States of America]
Eric D Whitman, MD - Form 483, 2020-12-07
$289 - Available for instant download
Issued On: December, 2020
Inspection Type: FDA 483
Site Name: Eric D Whitman, MD [Morristown / United States of America]
ALIEN MILLING TECHNOLOGIES - Form 483, 2020-12-01
$289 - Available for instant download
Issued On: December, 2020
Inspection Type: FDA 483
Site Name: ALIEN MILLING TECHNOLOGIES [Glendora / United States of America]
Starwest Botanicals, Inc - Form 483, 2020-12-01
$289 - Available for instant download
Issued On: December, 2020
Inspection Type: FDA 483
Site Name: Starwest Botanicals, Inc [Sacramento / United States of America]
Russ Davis Wholesale, Inc. - Form 483, 2020-12-14
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Russ Davis Wholesale, Inc. [Pueblo / United States of America]
Michael L. Levin, M.D. - Form 483, 2020-11-25
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Michael L. Levin, M.D. [Las Vegas / United States of America]
Neil Sheth, MD - Form 483, 2020-11-24
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Neil Sheth, MD [Glendale / United States of America]
Allure Labs, Inc - Form 483, 2020-11-23
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Allure Labs, Inc [Hayward / United States of America]
Marcello M. Rotta, MD - Form 483, 2020-11-23
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Marcello M. Rotta, MD [Denver / United States of America]
Paul A. Goepfert, MD. - Form 483, 2020-11-20
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Paul A. Goepfert, MD. [Birmingham / United States of America]
Shandong Anshun Pharmaceutical Co., Ltd. - Form 483, 2020-11-20
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Shandong Anshun Pharmaceutical Co., Ltd. [Shandong / China]
EO Products, LLC - Form 483, 2020-11-17
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: EO Products, LLC [San Rafael / United States of America]
Mark Adaimy MD - Form 483, 2020-11-16
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Mark Adaimy MD [Las Vegas / 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 [Yichang / China]
Ronald B. Natale, MD - Form 483, 2020-11-13
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Ronald B. Natale, MD [West Hollywood / United States of America]
Ira L. Berger, M.D. - EIR, 2020-11-13
$1190 - Available for instant download
Issued On: November, 2020
Inspection Type: EIR
Site Name: Ira L. Berger, M.D. [Potomac / United States of America]
Mark A Turner MD - EIR, 2020-11-13
$1190 - Available for instant download
Issued On: November, 2020
Inspection Type: EIR
Site Name: Mark A Turner MD [Meridian / United States of America]
Advanced Monitored Caregiving, Inc. - Form 483, 2020-11-12
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Advanced Monitored Caregiving, Inc. [New York / United States of America]
Life Science Outsourcing, Inc. - Form 483, 2020-11-12
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Life Science Outsourcing, Inc. [Brea / United States of America]
Lyophilization Services Of New England, Inc. (LSNE) - EIR, 2020-11-11
$1190 - Available for instant download
Issued On: November, 2020
Inspection Type: EIR
Site Name: Lyophilization Services Of New England, Inc. (LSNE) [Bedford / United States of America]
Lyophilization Services Of New England, Inc. (LSNE) - Form 483R, 2020-11-20
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483 Response
Site Name: Lyophilization Services Of New England, Inc. (LSNE) [Bedford / United States of America]
Lyophilization Services Of New England, Inc. (LSNE) - Form 483, 2020-11-11
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Lyophilization Services Of New England, Inc. (LSNE) [Bedford / United States of America]
BIOGEN, INC - Form 483, 2020-11-10
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: BIOGEN, INC [Cambridge / United States of America]
Biogen, Inc. - Form 483, 2020-11-10
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Biogen, Inc. [Cambridge / United States of America]
Biogen, Inc. - EIR, 2020-11-10
$1190 - Available for instant download
Issued On: November, 2020
Inspection Type: EIR
Site Name: Biogen, Inc. [Cambridge / United States of America]
New York Blood Center Enterprises - Form 483, 2020-11-09
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: New York Blood Center Enterprises [Melville / United States of America]
Julie Hoover-Fong, M.D. - EIR, 2020-11-06
$1190 - Available for instant download
Issued On: November, 2020
Inspection Type: EIR
Site Name: Julie Hoover-Fong, M.D. [Baltimore / United States of America]
BioMarin Pharmaceutical Inc. - EIR, 2020-11-06
$1190 - Available for instant download
Issued On: November, 2020
Inspection Type: EIR
Site Name: BioMarin Pharmaceutical Inc. [San Rafael / United States of America]
PETNET SOLUTIONS, INC. - EIR, 2020-11-06
$1190 - Available for instant download
Issued On: November, 2020
Inspection Type: EIR
Site Name: PETNET SOLUTIONS, INC. [Sacramento / United States of America]
Novel Laboratories, Inc. - Form 483, 2020-11-05
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Novel Laboratories, Inc. [Somerset / United States of America]
Novel Laboratories, Inc. - Form 483R, 2020-11-05
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483 Response
Site Name: Novel Laboratories, Inc. [Somerset / United States of America]
Tongda Fruit Juice & Beverage Liquan Co., Ltd. - Form 483, 2020-11-05
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Tongda Fruit Juice & Beverage Liquan Co., Ltd. [Liquan / China]
Paul Harmatz, M.D. - EIR, 2020-11-05
$1190 - Available for instant download
Issued On: November, 2020
Inspection Type: EIR
Site Name: Paul Harmatz, M.D. [Oakland / United States of America]
Lonza Biologics, Inc. - Form 483, 2020-11-03
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Lonza Biologics, Inc. [Portsmouth / United States of America]
World Club Supply Corp - Form 483, 2020-11-03
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: World Club Supply Corp [Orange / United States of America]
Lonza Biologics, Inc. - EIR, 2020-11-03
$1190 - Available for instant download
Issued On: November, 2020
Inspection Type: EIR
Site Name: Lonza Biologics, Inc. [Portsmouth / United States of America]
James Consolidated, Inc. - Form 483, 2020-11-03
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: James Consolidated, Inc. [Concord / United States of America]
Hopkinton Drug, Inc. - Form 483, 2020-11-10
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: Hopkinton Drug, Inc. [Hopkinton / United States of America]
AGC Biologics, Inc. - Form 483, 2020-11-02
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483
Site Name: AGC Biologics, Inc. [Bothell / United States of America]
AGC Biologics, Inc. - Form 483R, 2020-11-23
$289 - Available for instant download
Issued On: November, 2020
Inspection Type: FDA 483 Response
Site Name: AGC Biologics, Inc. [Bothell / United States of America]
AGC Biologics, Inc. - EIR, 2020-11-02
$1190 - Available for instant download
Issued On: November, 2020
Inspection Type: EIR
Site Name: AGC Biologics, Inc. [Bothell / United States of America]
Pharmaceutics International, Inc. - EIR, 2020-10-30
$1190 - Available for instant download
Issued On: October, 2020
Inspection Type: EIR
Site Name: Pharmaceutics International, Inc. [Cockeysville / United States of America]
Pharmaceutics International, Inc. - Form 483, 2020-10-30
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Pharmaceutics International, Inc. [Hunt Valley / United States of America]
B Braun Medical Inc - Form 483, 2020-10-30
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: B Braun Medical Inc [Daytona Beach / United States of America]
Shandong Anhong Pharmaceutical Co., Ltd. - Form 483, 2020-10-30
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Shandong Anhong Pharmaceutical Co., Ltd. [Linyi / China]
Pharmaceutics International, Inc. - EIR, 2020-10-30
$1190 - Available for instant download
Issued On: October, 2020
Inspection Type: EIR
Site Name: Pharmaceutics International, Inc. [Hunt Valley / United States of America]
Pharmaceutics International, Inc. - Form 483, 2020-10-30
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Pharmaceutics International, Inc. [Cockeysville / United States of America]
Advanced Nutriceuticals, LLC - Form 483, 2020-10-29
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Advanced Nutriceuticals, LLC [Indianapolis / United States of America]
Bankole Johnson MD - Form 483, 2020-10-28
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Bankole Johnson MD [Charlottesville / United States of America]
Frostime Llc - Form 483, 2020-10-28
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Frostime Llc [New York / United States of America]
Syntec Pharma Corp. - Form 483, 2020-10-28
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Syntec Pharma Corp. [Farmingdale / United States of America]
Sunshine Mills, Inc. - Form 483, 2020-10-27
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Sunshine Mills, Inc. [Tupelo / United States of America]
Berkshire Sterile Manufacturing, Inc. - Form 483R, 2020-10-27
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483 Response
Site Name: Berkshire Sterile Manufacturing, Inc. [Lee / United States of America]
Sunshine Mills, Inc. - Form 483R, 2020-11-11
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483 Response
Site Name: Sunshine Mills, Inc. [Tupelo / United States of America]
Berkshire Sterile Manufacturing, Inc. - Form 483, 2020-10-27
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Berkshire Sterile Manufacturing, Inc. [Lee / United States of America]
Medtronic Heart Valves Division - EIR, 2020-11-10
$1190 - Available for instant download
Issued On: October, 2020
Inspection Type: EIR
Site Name: Medtronic Heart Valves Division [Santa Ana / United States of America]
QUAGEN PHARMACEUTICALS LLC - Form 483, 2020-10-26
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: QUAGEN PHARMACEUTICALS LLC [West Caldwell / United States of America]
Medtronic Heart Valves Division - Form 483, 2020-10-26
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Medtronic Heart Valves Division [Santa Ana / United States of America]
Velocity Pharma LLC - Form 483, 2020-10-23
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Velocity Pharma LLC [Farmingdale / United States of America]
Viant AS&O Holdings, LLC - Form 483, 2020-10-23
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Viant AS&O Holdings, LLC [Orchard Park / United States of America]
MedisourceRx - Form 483, 2020-10-22
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: MedisourceRx [Los Alamitos / United States of America]
Patricia Kropf MD - Form 483, 2020-11-13
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Patricia Kropf MD [Philadelphia / United States of America]
BPC Plasma, Inc. - Form 483, 2020-10-21
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: BPC Plasma, Inc. [Youngstown / United States of America]
Jawad A. Qureshi MD - Form 483, 2020-10-21
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Jawad A. Qureshi MD [Grapevine / United States of America]
Eric Hollander MD - Form 483, 2020-10-20
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Eric Hollander MD [Bronx / United States of America]
James S. Cochran, MD - Form 483, 2020-10-29
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: James S. Cochran, MD [Dallas / United States of America]
Corcept Therapeutics Incorporated - EIR, 2020-10-19
$1190 - Available for instant download
Issued On: October, 2020
Inspection Type: EIR
Site Name: Corcept Therapeutics Incorporated [Menlo Park / United States of America]
Juno Therapeutics, Inc. - EIR, 2020-10-16
$1190 - Available for instant download
Issued On: October, 2020
Inspection Type: EIR
Site Name: Juno Therapeutics, Inc. [Bothell / United States of America]
Paul Harmatz, M.D. - Form 483, 2020-10-16
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Paul Harmatz, M.D. [Oakland / United States of America]
Ozlem Goker-Alpan, MD - EIR, 2020-11-25
$1190 - Available for instant download
Issued On: October, 2020
Inspection Type: EIR
Site Name: Ozlem Goker-Alpan, MD [Fairfax / United States of America]
Juno Therapeutics, Inc. - Form 483, 2020-10-16
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Juno Therapeutics, Inc. [Bothell / United States of America]
Unipack LLC - Form 483, 2020-10-16
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Unipack LLC [South Plainfield / United States of America]
Juno Therapeutics, Inc. - Form 483R, 2020-11-05
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483 Response
Site Name: Juno Therapeutics, Inc. [Bothell / United States of America]
Repro Lab - Form 483, 2020-10-16
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Ozlem Goker-Alpan, MD - Form 483, 2020-10-16
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Ozlem Goker-Alpan, MD [Fairfax / United States of America]
Lawrence M. Lehrner MD - Form 483, 2020-10-14
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Lawrence M. Lehrner MD [Las Vegas / United States of America]
Ascent Pharmaceuticals Inc - EIR, 2020-10-13
$1190 - Available for instant download
Issued On: October, 2020
Inspection Type: EIR
Site Name: Ascent Pharmaceuticals Inc [Central Islip / United States of America]
Bailey, Timothy S., MD - Form 483, 2020-10-13
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Bailey, Timothy S., MD [Escondido / United States of America]
Ascent Pharmaceuticals Inc - Form 483, 2020-10-13
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Ascent Pharmaceuticals Inc [Central Islip / United States of America]
Curexa - East, LLC dba Curexa - Form 483, 2020-10-09
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Curexa - East, LLC dba Curexa [Egg Harbor Township / United States of America]
Millers of Wyckoff, Inc. - Form 483R, 2020-10-19
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483 Response
Site Name: Millers of Wyckoff, Inc. [Wyckoff / United States of America]
Stokes Healthcare Inc. dba Epicur Pharma - Form 483, 2020-10-09
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Stokes Healthcare Inc. dba Epicur Pharma [Mount Laurel / United States of America]
Thoratec Corp. - EIR, 2020-10-09
$1190 - Available for instant download
Issued On: October, 2020
Inspection Type: EIR
Site Name: Thoratec Corp. [Pleasanton / United States of America]
Millers of Wyckoff, Inc. - Form 483, 2020-10-09
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Millers of Wyckoff, Inc. [Wyckoff / United States of America]
Larken Laboratories, Inc. - Form 483, 2020-10-23
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Larken Laboratories, Inc. [Canton / United States of America]
James L. Bicksel MD - Form 483, 2020-10-08
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: James L. Bicksel MD [Fairfax / United States of America]
Sannova Analytical LLC - EIR, 2020-10-07
$1190 - Available for instant download
Issued On: October, 2020
Inspection Type: EIR
Site Name: Sannova Analytical LLC [Somerset / United States of America]
Synapse Biomedical Inc - Form 483, 2020-10-07
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Synapse Biomedical Inc [Oberlin / United States of America]
Summa Health System IRB - Form 483, 2020-10-07
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Summa Health System IRB [Akron / United States of America]
California IVF Fertility Center - Form 483, 2020-10-07
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: California IVF Fertility Center [Sacramento / United States of America]
CPAPNEA Medical Supply - Form 483, 2020-10-07
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: CPAPNEA Medical Supply [Phoenix / United States of America]
Sannova Analytical LLC - Form 483, 2020-10-07
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: Sannova Analytical LLC [Somerset / United States of America]
Abiomed, Inc. - EIR, 2020-10-06
$1190 - Available for instant download
Issued On: October, 2020
Inspection Type: EIR
Site Name: Abiomed, Inc. [Danvers / United States of America]
MEDISCA Inc. - Form 483, 2020-10-06
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Site Name: MEDISCA Inc. [Plattsburgh / United States of America]
Providence Health and Services Washington Dba Providence Infusion Hospital Services - Form 483, 2020-10-05
$289 - Available for instant download
Issued On: October, 2020
Inspection Type: FDA 483
Manchester Tobacco & Candy Co. - EIR, 2020-10-02
$1190 - Available for instant download
Issued On: October, 2020
Inspection Type: EIR
Site Name: Manchester Tobacco & Candy Co. [Manchester / United States of America]