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Mak-System Corp. - Form 483, 2023-08-11
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Mak-System Corp. [Des Plaines / United States of America]
Univar Solutions USA Inc. - Form 483, 2023-08-11
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Univar Solutions USA Inc. [Cincinnati / United States of America]
Ultra Clean Systems, Inc. - Form 483, 2023-08-11
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Ultra Clean Systems, Inc. [Oldsmar / United States of America]
Logix Biosciences Inc. - Form 483, 2023-09-06
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Logix Biosciences Inc. [Monterey / United States of America]
Apex International Mfg., LLC - Form 483, 2023-08-11
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Apex International Mfg., LLC [Chaska / United States of America]
Arrow Reliance Inc - Form 483, 2023-08-11
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Arrow Reliance Inc [Tukwila / United States of America]
Sojitz Corporation of America - Form 483, 2023-08-11
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Sojitz Corporation of America [New York / United States of America]
SOFIE Co. dba SOFIE - Form 483, 2023-11-02
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: SOFIE Co. dba SOFIE [Totowa / United States of America]
Henan Dongtai Pharm Co., Ltd. - EIR, 2024-01-17
$1190 - Available for instant download
Issued On: August, 2023
Inspection Type: EIR
ABS Corporation - Form 483, 2023-08-11
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: ABS Corporation [Omaha / United States of America]
Genentech, Inc. - Form 483, 2023-08-11
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Genentech, Inc. [South San Francisco / United States of America]
Micobe Inc - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Coupler LLC - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Coupler LLC [West Chester / United States of America]
PT Solutions LLC - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: PT Solutions LLC [Brunswick / United States of America]
Surgitech Inc - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Surgitech Inc [Carlsbad / United States of America]
Dendreon Pharmaceuticals LLC - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Dendreon Pharmaceuticals LLC [Seal Beach / United States of America]
BrightGene Bio-Medical Technology Co., Ltd. - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: BrightGene Bio-Medical Technology Co., Ltd. [Suzhou / China]
Cangene BioPharma, LLC - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Cangene BioPharma, LLC [Baltimore / United States of America]
Titan Manufacturing, Inc. - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Titan Manufacturing, Inc. [Fall River / United States of America]
Pharmatech Inc. - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Pharmatech Inc. [Lindon / United States of America]
Microcision Llc - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Microcision Llc [Pennsauken / United States of America]
INOVAT Industria Farmaceutica LTDA. - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: INOVAT Industria Farmaceutica LTDA. [Guarulhos / Brazil]
Aeton Medical - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Aeton Medical [Pennsauken / United States of America]
Anika Therapeutics Inc - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Anika Therapeutics Inc [Bedford / United States of America]
California Center for Reproductive Health - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: California Center for Reproductive Health [Encino / United States of America]
Veterans Administration Hospital Blood Bank - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Veterans Administration Hospital Blood Bank [Fort Harrison / United States of America]
Burpee Materials Technology, LLC - Form 483, 2023-08-08
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Burpee Materials Technology, LLC [Eatontown / United States of America]
Command Medical Products, Inc. - Form 483, 2023-08-08
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Command Medical Products, Inc. [Ormond Beach / United States of America]
ARYZ Trading LLC - Form 483, 2023-08-08
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: ARYZ Trading LLC [Dearborn / United States of America]
Sciarra Laboratories, Inc. - Form 483, 2023-08-07
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Sciarra Laboratories, Inc. [Hicksville / United States of America]
Akeso Biopharma Co., Ltd. - Form 483, 2023-08-07
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
True Function Laboratory, Inc. - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: True Function Laboratory, Inc. [La Mesa / United States of America]
Lewis, Karl D. MD - Form 483, 2023-09-12
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Lewis, Karl D. MD [Aurora / United States of America]
Steven Sarkisian, M.D - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Steven Sarkisian, M.D [Oklahoma City / United States of America]
MARKSANS PHARMA LIMITED - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: MARKSANS PHARMA LIMITED [Mormugao / India]
TEH SENG PHARMACEUTICAL MFG. CO., LTD. 3RD PLANT - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: TEH SENG PHARMACEUTICAL MFG. CO., LTD. 3RD PLANT [Yongkang District / Taiwan]
Andrew C. Siesennop, MD - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Andrew C. Siesennop, MD [Boston / United States of America]
Biorez, Inc - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Biorez, Inc [New Haven / United States of America]
Prime Lab, LLC - Form 483, 2023-09-14
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Prime Lab, LLC [Sabanetas / Puerto Rico]
Catalent Argentina S.A.I.y C. - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Catalent Argentina S.A.I.y C. [Loma Hermosa / Argentina]
Asept Pak Inc. - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Asept Pak Inc. [Malone / United States of America]
Mead Johnson (Asia Pacific) Pte. Ltd. - EIR, 2023-11-05
$1190 - Available for instant download
Issued On: August, 2023
Inspection Type: EIR
Site Name: Mead Johnson (Asia Pacific) Pte. Ltd. [Singapore / Singapore]
Mark A. Stein, Ph.D. - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Mark A. Stein, Ph.D. [Seattle / United States of America]
Firas B. Badin, M.D. - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Firas B. Badin, M.D. [Lexington / United States of America]
Shanghai Henlius Biologics Co.,Ltd - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Shanghai Henlius Biologics Co.,Ltd [Songjiang / China]
Roslin Cell Therapies Limited - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Roslin Cell Therapies Limited [Edinburgh / United Kingdom of Great Britain and Northern Ireland]
Ensemble Orthopedics, Inc. - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Ensemble Orthopedics, Inc. [West Lake Hills / United States of America]
Ackermann Usa Inc - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Ackermann Usa Inc [Bayport / United States of America]
Inopak Ltd - Form 483, 2023-08-03
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Lions Eye Bank For Long Island - Form 483, 2023-08-03
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Lions Eye Bank For Long Island [Valley Stream / United States of America]
Lohxa - Form 483, 2023-08-03
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Lohxa [Worcester / United States of America]
InVitroCare, Inc - Form 483, 2023-08-03
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: InVitroCare, Inc [Frederick / United States of America]
Zhuhai United Laboratories Co., Ltd. - Form 483, 2023-08-03
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Zhuhai United Laboratories Co., Ltd. [Jinwan / China]
Hygeia II Medical Group, Inc. - Form 483, 2023-08-02
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Hygeia II Medical Group, Inc. [Carlsbad / United States of America]
Jeanne-Elyse G. Cedeno, M.D. - Form 483, 2023-08-08
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Jeanne-Elyse G. Cedeno, M.D. [Pembroke Pines / United States of America]
Reciprocal Labs Corporation - Form 483, 2023-08-02
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Reciprocal Labs Corporation [Madison / United States of America]
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma - Form 483, 2023-08-02
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
CO-AX Technology Inc - Form 483, 2023-08-02
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: CO-AX Technology Inc [Solon / United States of America]
Sovereign Pharmaceuticals, LLC - Form 483, 2023-08-02
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Sovereign Pharmaceuticals, LLC [Fort Worth / United States of America]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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)]
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]