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Kedrion S.p.A. - Form 483, 2022-06-24
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Kedrion S.p.A. [Gallicano / Italy]
Takeda Manufacturing Austria AG - Form 483, 2022-06-24
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Jeffrey M. Steinberg, M.D., Incorporated The Fertility Institutes, New York - Form 483, 2022-06-23
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Biotronik SE & Co. KG - Form 483, 2022-06-23
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Biotronik SE & Co. KG [Berlin / Germany]
Glenmark Pharmaceuticals Limited - Form 483, 2022-06-22
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Knox Medical Diagnostics, Inc. - Form 483, 2022-06-21
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Knox Medical Diagnostics, Inc. [San Francisco / United States of America]
TAIRGI TREAD-LIA BAILE NA SCEILGE TEORANTA (DbA Ballinskelligs Veterinary Products [BVP]) - Form 483, 2022-06-17
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
S&B Pharma LLC DBA Alkem Laboratories - Form 483, 2022-06-17
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: S&B Pharma LLC DBA Alkem Laboratories [Fenton / United States of America]
Nang Kuang Pharmaceutical Co. Ltd. - Form 483, 2022-06-16
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Nang Kuang Pharmaceutical Co. Ltd. [Yong Kang Qu / Taiwan]
Logosys Logistik GmbH - Form 483, 2022-06-15
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Logosys Logistik GmbH [Darmstadt / Germany]
Karl Storz Endovision, Inc. - Form 483, 2022-06-14
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Karl Storz Endovision, Inc. [Charlton / United States of America]
MedTek Skin Care, Inc. d/b/a UVBiotek - Form 483, 2022-06-10
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: MedTek Skin Care, Inc. d/b/a UVBiotek [Hudson Falls / United States of America]
Merz Pharma GmbH & Co. KGaA - Form 483, 2022-06-10
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Seattle Sperm Bank, LLC - Form 483, 2022-06-10
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Seattle Sperm Bank, LLC [La Jolla / United States of America]
FARMAKEIO OUTSOURCING LLC - Form 483, 2022-06-14
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: FARMAKEIO OUTSOURCING LLC [Southlake / United States of America]
Leatherbrook Holsteins, LLC - Form 483, 2022-06-10
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Leatherbrook Holsteins, LLC [Americus / United States of America]
J.M. Smucker LLC - Form 483, 2022-07-06
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: J.M. Smucker LLC [Lexington / United States of America]
Hikma Injectables USA Inc. - Form 483, 2022-06-08
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Hikma Injectables USA Inc. [Dayton / United States of America]
Electroskip, Llc - Form 483, 2022-06-07
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Electroskip, Llc [Buffalo / United States of America]
Denker, Mark S, MD PA - Form 483, 2022-06-06
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Denker, Mark S, MD PA [Boca Raton / United States of America]
Donor Network of Arizona - EIR, 2022-06-06
$1190 - Available for instant download
Issued On: June, 2022
Inspection Type: EIR
Site Name: Donor Network of Arizona [Tempe / United States of America]
Emily K. Curran, M.D. - Form 483, 2022-06-03
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Emily K. Curran, M.D. [Cincinnati / United States of America]
Mcminnville Workholding Company, Inc. - Form 483, 2022-06-03
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Mcminnville Workholding Company, Inc. [Mcminnville / United States of America]
BK Medical Holding Company - Form 483, 2022-05-27
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: BK Medical Holding Company [Burlington / United States of America]
American Health Packaging - EIR, 2022-05-27
$1190 - Available for instant download
Issued On: May, 2022
Inspection Type: EIR
Site Name: American Health Packaging [Columbus / United States of America]
KOBAYASHI America Manufacturing, LLC - Form 483, 2022-05-27
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: KOBAYASHI America Manufacturing, LLC [Dalton / United States of America]
Steven C. Kester, M.D. - Form 483, 2022-05-27
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Steven C. Kester, M.D. [Pompano Beach / United States of America]
Kinbio LTD - Form 483, 2022-05-26
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Kinbio LTD [Rehovot / Israel]
K2 TRADING INC. - Form 483, 2022-05-25
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: K2 TRADING INC. [Hackensack / United States of America]
Merck Biodevelopment - Form 483, 2022-05-24
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Merck Biodevelopment [Martillac / France]
Karl Storz Endoscopy America Inc - Form 483, 2022-05-24
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Karl Storz Endoscopy America Inc [Auburn / United States of America]
Berkshire Sterile Manufacturing, Inc. - Form 483, 2022-05-23
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Berkshire Sterile Manufacturing, Inc. [Lee / United States of America]
Berkshire Sterile Manufacturing, Inc. - Form 483R, 2022-05-23
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483 Response
Site Name: Berkshire Sterile Manufacturing, Inc. [Lee / United States of America]
Cantoro Food Market - Form 483, 2022-05-21
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Cantoro Food Market [Plymouth / United States of America]
Glenmark Pharmaceuticals Limited - Form 483, 2022-05-20
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Glenmark Pharmaceuticals Limited [Bardez / India]
Brock A. Andersen, M.D. - Form 483, 2022-05-20
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Brock A. Andersen, M.D. [Fruitland / United States of America]
Sartorius Korea Biotech Co., LLC. - Form 483, 2022-05-20
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Sartorius Korea Biotech Co., LLC. [Bundang-Gu / Korea (Republic of)]
Kenneth J Maverick, M.D. - Form 483, 2022-05-20
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Kenneth J Maverick, M.D. [San Antonio / United States of America]
Deepak C. D'Souza, M.D. - Form 483, 2022-05-20
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Deepak C. D'Souza, M.D. [West Haven / United States of America]
Alyk Inc. - Form 483, 2022-05-20
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Akorn Operating Company LLC (dba Akorn) - Form 483, 2022-05-17
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Akorn Operating Company LLC (dba Akorn) [Somerset / United States of America]
Skyless LLC - Form 483, 2022-05-27
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Skyless LLC [Real / Puerto Rico]
Novo Nordisk Pharmaceutical Industries, LP - Form 483, 2022-05-13
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Novo Nordisk Pharmaceutical Industries, LP [Clayton / United States of America]
Maxkron Machine, LLC - Form 483, 2022-05-13
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Maxkron Machine, LLC [Valencia / United States of America]
Novo Nordisk Pharmaceutical Industries, LP - EIR, 2022-06-02
$1190 - Available for instant download
Issued On: May, 2022
Inspection Type: EIR
Site Name: Novo Nordisk Pharmaceutical Industries, LP [Clayton / United States of America]
New York Fertility Medical Practice, PLLC - Form 483, 2022-05-12
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: New York Fertility Medical Practice, PLLC [New York / United States of America]
Tropical Bakery Wholesale Corp - Form 483, 2022-05-12
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Tropical Bakery Wholesale Corp [Hialeah / United States of America]
Nukemed, Inc dba SpectronRx - Form 483, 2022-05-12
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Nukemed, Inc dba SpectronRx [South Bend / United States of America]
Nukemed, Inc dba SpectronRx - EIR, 2022-05-12
$1190 - Available for instant download
Issued On: May, 2022
Inspection Type: EIR
Site Name: Nukemed, Inc dba SpectronRx [South Bend / United States of America]
Kearney, Susan L., M.D., Clinical Investigator - Form 483, 2022-05-10
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Kearney, Susan L., M.D., Clinical Investigator [Minneapolis / United States of America]
Shahrukh A. Kureishy, MD - Form 483, 2022-05-09
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Shahrukh A. Kureishy, MD [Mckinney / United States of America]
Spok, Inc. - Form 483, 2022-04-29
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Spok, Inc. [Alexandria / United States of America]
St Luke's Hospital Assisted Reproductive Technology Lab - Form 483, 2022-04-29
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: St Luke's Hospital Assisted Reproductive Technology Lab [Chesterfield / United States of America]
Legacy Pharmaceutical Packaging, LLC - Form 483, 2022-04-27
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Legacy Pharmaceutical Packaging, LLC [Earth City / United States of America]
Legacy Pharmaceutical Packaging, LLC - Form 483R, 2022-05-17
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483 Response
Site Name: Legacy Pharmaceutical Packaging, LLC [Earth City / United States of America]
Mikart, LLC - EIR, 2022-04-29
$1190 - Available for instant download
Issued On: April, 2022
Inspection Type: EIR
New York Cryo - Form 483, 2022-04-25
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: New York Cryo [Great Neck / United States of America]
New York Cryo - EIR, 2022-04-25
$1190 - Available for instant download
Issued On: April, 2022
Inspection Type: EIR
Site Name: New York Cryo [Great Neck / United States of America]
Kappa Laboratories, Inc. - Form 483, 2022-04-22
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Kappa Laboratories, Inc. [Miami / United States of America]
David M. Lubeck MD - Form 483, 2022-04-20
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: David M. Lubeck MD [Orland Park / United States of America]
Eksa Mills, S.A. de C.V. - Form 483, 2022-04-19
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Eksa Mills, S.A. de C.V. [Atlixco / Mexico]
Amarillo VA Health Care System - Blood Bank - Form 483, 2022-04-19
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Amarillo VA Health Care System - Blood Bank [Amarillo / United States of America]
KYOWA HAKKO BIO CO., LTD. - Form 483, 2022-04-15
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: KYOWA HAKKO BIO CO., LTD. [Kyowacho / Japan]
Rhode Island Blood Center, a Division of New York Blood Center, Inc., Westerly Donor Center - Form 483, 2022-04-15
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Lynn Oaks Compounding Pharmacy - Form 483, 2022-04-15
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Lynn Oaks Compounding Pharmacy [Thousand Oaks / United States of America]
Kyowa Hakko Bio Co., Ltd. - Form 483, 2022-04-15
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Kyowa Hakko Bio Co., Ltd. [Kyowacho / Japan]
Suncoast Community Blood Bank Inc - Form 483, 2022-04-13
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Suncoast Community Blood Bank Inc [Sarasota / United States of America]
Eskayef Pharmaceuticals Limited - Form 483, 2022-04-13
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Eskayef Pharmaceuticals Limited [Tongi / Bangladesh]
Merck S.A. de C.V. - Form 483, 2022-04-08
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Merck S.A. de C.V. [Zona Ind Industrial Alce Blanco / Mexico]
Meiji Seika Pharmatech Co., Ltd. - Form 483, 2022-04-08
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Meiji Seika Pharmatech Co., Ltd. [Kamonomiya / Japan]
Weeks & Leo Co., Inc. - EIR, 2022-04-07
$1190 - Available for instant download
Issued On: April, 2022
Inspection Type: EIR
Site Name: Weeks & Leo Co., Inc. [Clive / United States of America]
Weeks & Leo Co., Inc. - Form 483, 2022-04-07
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Weeks & Leo Co., Inc. [Clive / United States of America]
Weeks & Leo Co., Inc. - Form 483R, 2022-04-27
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483 Response
Site Name: Weeks & Leo Co., Inc. [Clive / United States of America]
Kwokcheng Enterprise, Inc. dba Fullei Fresh - Form 483, 2022-04-06
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Kwokcheng Enterprise, Inc. dba Fullei Fresh [Miami / United States of America]
Brookfield Medical/Surgical Supplies, Inc. - Form 483, 2022-04-04
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Brookfield Medical/Surgical Supplies, Inc. [Brookfield / United States of America]
Sher Fertility Solutions New York - Form 483, 2022-04-01
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Sher Fertility Solutions New York [New York / United States of America]
Ochsner Health System Blood Bank - Form 483, 2022-03-31
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Ochsner Health System Blood Bank [New Orleans / United States of America]
Klocke of America, Inc. - Form 483, 2022-03-30
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Klocke of America, Inc. [Fort Myers / United States of America]
Unipack LLC - Form 483, 2022-03-25
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Unipack LLC [South Plainfield / United States of America]
Nancy Kim, M.D. - Form 483, 2022-03-25
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Nancy Kim, M.D. [Scottsdale / United States of America]
Parker Veterinary Clinic - Form 483, 2022-03-23
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Parker Veterinary Clinic [Parker / United States of America]
EINSTEIN WORKS, LLC - Form 483, 2022-03-23
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: EINSTEIN WORKS, LLC [Houston / United States of America]
Element Materials Technology Oakland - Concord Inc. - Form 483R, 2022-03-22
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483 Response
Site Name: Element Materials Technology Oakland - Concord Inc. [Concord / United States of America]
Element Materials Technology Oakland - Concord Inc. - Form 483, 2022-03-24
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Element Materials Technology Oakland - Concord Inc. [Concord / United States of America]
Allstar Marketing Group Llc - Form 483, 2022-03-21
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Allstar Marketing Group Llc [Hawthorne / United States of America]
Fresenius Kabi USA, LLC - Form 483, 2022-03-18
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Fresenius Kabi USA, LLC [North Andover / United States of America]
Pajunk Medical Systems, L.P. - Form 483, 2022-03-18
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Pajunk Medical Systems, L.P. [Alpharetta / United States of America]
Bryant Ranch Prepack - Form 483, 2022-03-17
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Bryant Ranch Prepack [Burbank / United States of America]
KORR Medical Technologies, Inc. - Form 483, 2022-03-17
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: KORR Medical Technologies, Inc. [West Valley City / United States of America]
Dr. J SkinClinic, Inc. - Form 483, 2022-03-17
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Dr. J SkinClinic, Inc. [Cerritos / United States of America]
The Christ Hospital Health Network - EIR, 2022-03-15
$1190 - Available for instant download
Issued On: March, 2022
Inspection Type: EIR
Site Name: The Christ Hospital Health Network [Cincinnati / United States of America]
KEYBIO - Form 483, 2022-03-11
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: KEYBIO [Plan-De-Cuques / France]
Burbank Dental Lab Inc - Form 483, 2022-03-11
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Burbank Dental Lab Inc [Burbank / United States of America]
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding - Form 483, 2022-03-10
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Hendrick Regional Laboratory Transfusion Services - Form 483, 2022-03-10
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Hendrick Regional Laboratory Transfusion Services [Abilene / United States of America]
Musculoskeletal Transplant Foundation, Inc. - EIR, 2022-03-09
$1190 - Available for instant download
Issued On: March, 2022
Inspection Type: EIR
Site Name: Musculoskeletal Transplant Foundation, Inc. [Edison / United States of America]
Hendrick Regional Blood Center - Form 483, 2022-03-07
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Hendrick Regional Blood Center [Abilene / United States of America]
Mid-Continent Packaging, Inc. - Form 483, 2022-03-07
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Mid-Continent Packaging, Inc. [Enid / United States of America]
Kite Pharma, Inc. - EIR, 2022-04-05
$1190 - Available for instant download
Issued On: March, 2022
Inspection Type: EIR
Site Name: Kite Pharma, Inc. [Frederick / United States of America]
Spark Therapeutics, Inc. - Form 483, 2022-03-04
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Spark Therapeutics, Inc. [Philadelphia / United States of America]