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Fresenius Medical Care Holdings, Inc. - Form 483, 2023-08-02
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Fresenius Medical Care Holdings, Inc. [Waltham / United States of America]
Healing Innovations, Inc - Form 483, 2023-08-01
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Healing Innovations, Inc [Nashville / United States of America]
SpineSmith Holdings, LLC - Form 483, 2023-08-01
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: SpineSmith Holdings, LLC [Austin / United States of America]
Dwayne Logan, M.D. - Form 483, 2023-08-01
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Dwayne Logan, M.D. [Huntington Beach / United States of America]
KGR Distribution Corp. - Form 483, 2023-08-01
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: KGR Distribution Corp. [Passaic / United States of America]
3 Machados Dairy Inc. - Form 483, 2023-08-01
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: 3 Machados Dairy Inc. [Merced / United States of America]
SGS North America Inc. - Form 483, 2023-08-01
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: SGS North America Inc. [Fairfield / United States of America]
Swabplus, L.P. - Form 483, 2023-08-01
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Swabplus, L.P. [Rancho Cucamonga / United States of America]
Mays Dairy - Form 483, 2023-07-31
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Central Admixture Pharmacy Services, Inc. - Form 483, 2023-07-31
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Central Admixture Pharmacy Services, Inc. [Phoenix / United States of America]
5000 Years Foods, Inc. - Form 483, 2023-07-31
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: 5000 Years Foods, Inc. [Chicago / United States of America]
Cleveland Medical Devices Inc - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Cleveland Medical Devices Inc [Cleveland / United States of America]
Indira Brar, M.D. - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Indira Brar, M.D. [Detroit / United States of America]
Virbac Corporation - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Virbac Corporation [Bridgeton / United States of America]
Pelex Medical of Texas - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Pelex Medical of Texas [Lubbock / United States of America]
APOTHECON PHARMACEUTICALS PRIVATE LIMITED - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: APOTHECON PHARMACEUTICALS PRIVATE LIMITED [Padra / India]
Zoetis Manufacturing & Research Spain, S.L. - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Zoetis Manufacturing & Research Spain, S.L. [La Vall De Bianya / Spain]
Saint-Gobain Perofrmance Plastics, Inc. - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Saint-Gobain Perofrmance Plastics, Inc. [Portage / United States of America]
Organo Sintesis, S.A. de C.V. - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Organo Sintesis, S.A. de C.V. [Capulhuac / Mexico]
Insulet Corporation - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Insulet Corporation [Acton / United States of America]
Full Range Rehab LLC - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Full Range Rehab LLC [West Chester / United States of America]
King Bio Inc - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: King Bio Inc [Asheville / United States of America]
Omeza - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Omeza [Sarasota / United States of America]
Charles River Laboratories Inc. - EIR, 2023-09-05
$1190 - Available for instant download
Issued On: July, 2023
Inspection Type: EIR
Site Name: Charles River Laboratories Inc. [Frederick / United States of America]
AIRGAS USA, LLC - Form 483, 2023-07-27
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: AIRGAS USA, LLC [Linthicum Heights / United States of America]
Aeropres Corp - Form 483, 2023-07-27
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Aeropres Corp [Sibley / United States of America]
Nelson Environmental Technologies, Inc. - Form 483, 2023-07-27
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Nelson Environmental Technologies, Inc. [Stafford / United States of America]
ImClone Systems LLC - Form 483, 2023-07-27
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: ImClone Systems LLC [Branchburg / United States of America]
Williams & Son Livestock, LLC. - Form 483, 2023-07-27
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Williams & Son Livestock, LLC. [London / United States of America]
Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery - Form 483, 2023-07-26
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
POET Corning Bioprocessing LLC - Form 483, 2023-07-26
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: POET Corning Bioprocessing LLC [Corning / United States of America]
Louisiana State University Health Sciences Center - Form 483, 2023-07-26
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Louisiana State University Health Sciences Center [New Orleans / United States of America]
POET Bioprocessing-Emmetsburg LLC - Form 483, 2023-07-25
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: POET Bioprocessing-Emmetsburg LLC [Emmetsburg / United States of America]
Novo Nordisk US Bio Production Inc. - Form 483, 2023-07-25
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Novo Nordisk US Bio Production Inc. [West Lebanon / United States of America]
Kofinas Fertility Group - Form 483, 2023-07-25
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Kofinas Fertility Group [New York / United States of America]
G21 USA, Inc. - Form 483, 2023-07-25
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: G21 USA, Inc. [New York / United States of America]
Ardelyx, Inc. - Form 483, 2023-07-24
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Ardelyx, Inc. [Fremont / United States of America]
Advanced Cosmetic Research Laboratories - Form 483, 2023-07-24
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Advanced Cosmetic Research Laboratories [Chatsworth / United States of America]
Ascension Clinical Research Institute IRB - Form 483, 2023-07-24
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Ascension Clinical Research Institute IRB [Milwaukee / United States of America]
BALT USA, LLC - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: BALT USA, LLC [Irvine / United States of America]
Genesis Biologics, Inc. - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Genesis Biologics, Inc. [Irvine / United States of America]
Oximeter Plus, Inc - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Oximeter Plus, Inc [Roslyn Heights / United States of America]
Alan G. Garscadden, M.D. - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Alan G. Garscadden, M.D. [Colorado Springs / United States of America]
PBM Nutritionals, LLC - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: PBM Nutritionals, LLC [Covington / United States of America]
Vericel Corporation - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Vericel Corporation [Cambridge / United States of America]
Lonza Biologics, Inc. - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Lonza Biologics, Inc. [Portsmouth / United States of America]
S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED [Bueng / Thailand]
POET Biorefining-Hanlontown - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: POET Biorefining-Hanlontown [Hanlontown / United States of America]
Catalent Pharma Solutions, LLC - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Catalent Pharma Solutions, LLC [Saint Petersburg / United States of America]
Cardiva Medical, Inc. - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Cardiva Medical, Inc. [Santa Clara / United States of America]
KOLMAR KOREA CO., LTD Gwanjeong 2 branch - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: KOLMAR KOREA CO., LTD Gwanjeong 2 branch [Sejong / Korea (Republic of)]
Lonza Biologics, Inc. - Form 483R, 2023-08-09
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483 Response
Site Name: Lonza Biologics, Inc. [Portsmouth / United States of America]
Cosette Pharmaceuticals NC Laboratories, LLC - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Cosette Pharmaceuticals NC Laboratories, LLC [Lincolnton / United States of America]
Hetero Labs Limited - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Hetero Labs Limited [Hyderabad / India]
Aurobindo Pharma Limited - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Aurobindo Pharma Limited [Hyderabad / India]
BIOCON SDN.BHD. - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: BIOCON SDN.BHD. [Iskandar Puteri / Malaysia]
AKI, Inc. dba Arcade Beauty - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: AKI, Inc. dba Arcade Beauty [Chattanooga / United States of America]
Creation Technologies Wisconsin Inc - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Creation Technologies Wisconsin Inc [Oak Creek / United States of America]
Keystone Industries - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Keystone Industries [Swedesboro / United States of America]
Precision Align LLC - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Precision Align LLC [Fort Lauderdale / United States of America]
Zochem ULC - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Zochem ULC [Brampton / Canada]
SPINE INNOVATION, LLC - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: SPINE INNOVATION, LLC [Del Mar / United States of America]
International Medical Devices, Inc - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: International Medical Devices, Inc [Beverly Hills / United States of America]
American Regent, Inc. - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: American Regent, Inc. [Hilliard / United States of America]
Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API) - EIR, 2025-05-13
$1190 - Available for instant download
Issued On: July, 2023
Inspection Type: EIR
Site Name: Zhejiang Xianju Pharmaceutical Co. Ltd.(Yangfu API) [Xianju / China]
MD Tox Laboratory - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: MD Tox Laboratory [Irvine / United States of America]
Inmar Supply Chain Solutions, LLC - Form 483, 2023-07-19
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Inmar Supply Chain Solutions, LLC [Arlington / United States of America]
Blaken Farms - Form 483, 2023-07-19
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Blaken Farms [Melrose / United States of America]
Naturavit Inc - Form 483, 2023-07-19
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Merry-Water Farms, Inc. - Form 483, 2023-07-19
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Merry-Water Farms, Inc. [Lake Geneva / United States of America]
Wisconsin Aluminum Foundry Co, Inc. - Form 483, 2023-07-19
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Wisconsin Aluminum Foundry Co, Inc. [Manitowoc / United States of America]
Glaukos Corporation - EIR, 2023-08-01
$1190 - Available for instant download
Issued On: July, 2023
Inspection Type: EIR
Site Name: Glaukos Corporation [San Clemente / United States of America]
Whele LLC DBA Perch - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Whele LLC DBA Perch [Boston / United States of America]
GE Healthcare - Repair Operations Center - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: GE Healthcare - Repair Operations Center [Oak Creek / United States of America]
Teva API India Private Ltd. - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Med-Surgical Services Inc., dba CBYON - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Med-Surgical Services Inc., dba CBYON [Tempe / United States of America]
BioIntegrate Inc - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: BioIntegrate Inc [Morrow / United States of America]
Synthasome, Inc - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Synthasome, Inc [Del Mar / United States of America]
Dextrum Laboratories Inc. - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Dextrum Laboratories Inc. [Miami / United States of America]
Product Packaging West, Inc. - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Product Packaging West, Inc. [North Hollywood / United States of America]
Oostdam Dairy - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Oostdam Dairy [San Jacinto / United States of America]
Bahadir USA LLC - Form 483, 2023-07-17
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Bahadir USA LLC [Penns Grove / United States of America]
A-OX WELDING SUPPLY CO., INC. - Form 483, 2023-07-17
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: A-OX WELDING SUPPLY CO., INC. [Sioux Falls / United States of America]
Culligan Soft Water Service Co - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Culligan Soft Water Service Co [Minnetonka / United States of America]
Altasciences Preclinical Seattle, LLC - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Altasciences Preclinical Seattle, LLC [Everett / United States of America]
Tugusto Foods, Inc. - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Tugusto Foods, Inc. [Minillas / Puerto Rico]
Fettech - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Fettech [Davie / United States of America]
Immuno-Mycologics, Inc - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Immuno-Mycologics, Inc [Norman / United States of America]
Altasciences Preclinical Seattle, LLC - EIR, 2023-08-22
$1190 - Available for instant download
Issued On: July, 2023
Inspection Type: EIR
Site Name: Altasciences Preclinical Seattle, LLC [Everett / United States of America]
Torito Brands LLC - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Torito Brands LLC [Deerfield Beach / United States of America]
Preservation Solutions, Inc. - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Preservation Solutions, Inc. [Elkhorn / United States of America]
Billings Clinic Innovative Fertility - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Billings Clinic Innovative Fertility [Billings / United States of America]
Gland Pharma Limited - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Gland Pharma Limited [Hyderabad / India]
Eco Lips, Inc. - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Eco Lips, Inc. [Cedar Rapids / United States of America]
Aspire Pharmaceuticals Inc. - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Aspire Pharmaceuticals Inc. [Somerset / United States of America]
Sentara Enterprises dba Sentara Infusion Services (Blue Ridge) - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
ST Pharm Co., Ltd. - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: ST Pharm Co., Ltd. [Danwon-Gu / Korea (Republic of)]
Roche Diagnostics GmbH - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Roche Diagnostics GmbH [Mannheim / Germany]
Johns Dental Laboratories Inc. - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Johns Dental Laboratories Inc. [Terre Haute / United States of America]
Moo Mountain Milk Inc - Form 483, 2023-07-13
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Moo Mountain Milk Inc [Burley / United States of America]