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Sterigenics U.S., LLC - EIR, 2023-08-24
$1190 - Available for instant download
Issued On: August, 2023
Inspection Type: EIR
Site Name: Sterigenics U.S., LLC [Fort Worth / United States of America]
Forsure Medical Products, LLC - Form 483, 2023-08-17
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Forsure Medical Products, LLC [Miami / United States of America]
Pingdingshan Tianjing Plant Albumen Co., Ltd. - Form 483, 2023-08-17
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Pingdingshan Tianjing Plant Albumen Co., Ltd. [Pingdingshan / China]
Angela D. Ritter, M.D. - Form 483, 2023-08-17
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Angela D. Ritter, M.D. [Gainesville / United States of America]
ACI Medical LLC - Form 483, 2023-08-17
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: ACI Medical LLC [San Marcos / United States of America]
Sunshine USA, LLC - Form 483, 2023-08-17
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Sunshine USA, LLC [Kingsport / United States of America]
Nova Southeastern University IRB #1 - Form 483, 2023-08-17
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Nova Southeastern University IRB #1 [Fort Lauderdale / United States of America]
Contech Medical, Inc. - Form 483, 2023-08-17
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Contech Medical, Inc. [Providence / United States of America]
Pingdingshan Tianjing Plant Albumen Co., Ltd. - Form 483, 2023-08-17
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Pingdingshan Tianjing Plant Albumen Co., Ltd. [Pingdingshan / China]
PERMONTE USA CORP - Form 483, 2023-08-17
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: PERMONTE USA CORP [North Hollywood / United States of America]
Welch Allyn Inc - Form 483, 2023-08-17
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Welch Allyn Inc [Skaneateles / United States of America]
Myriad Medical, LLC - Form 483, 2023-08-17
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Myriad Medical, LLC [Tampa / United States of America]
Zyno Medical LLC - Form 483, 2023-09-06
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Zyno Medical LLC [Natick / United States of America]
Aslan T Turer, M.D. - Form 483, 2023-08-16
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Aslan T Turer, M.D. [Dallas / United States of America]
Pure Simple Products aka Northern Elderberry - Form 483, 2023-08-16
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Pure Simple Products aka Northern Elderberry [Traverse City / United States of America]
Green Sprouts - Form 483, 2023-08-16
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Green Sprouts [Asheville / United States of America]
Applevalley Organics INC, Corporation - Form 483, 2023-08-16
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Applevalley Organics INC, Corporation [New York / United States of America]
Emergent Biodefense Operations Lansing LLC - Form 483R, 2023-09-07
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483 Response
Site Name: Emergent Biodefense Operations Lansing LLC [Canton / United States of America]
Refine USA, LLC - Form 483, 2023-08-16
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Refine USA, LLC [Jacksonville Beach / United States of America]
InfuTronix LLC - Form 483, 2023-09-07
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: InfuTronix LLC [Natick / United States of America]
Emergent Biodefense Operations Lansing LLC - Form 483, 2023-08-16
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Emergent Biodefense Operations Lansing LLC [Canton / United States of America]
Spinergy, Inc (SM Power LLC) - Form 483, 2023-08-15
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Spinergy, Inc (SM Power LLC) [San Marcos / United States of America]
Sterigenics U.S., LLC - Form 483, 2023-08-15
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Sterigenics U.S., LLC [Rockaway / United States of America]
AMMAN PHARMACEUTICAL INDUSTRIES - Form 483, 2023-08-15
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Glens Falls Hospital IRB - Form 483, 2023-08-14
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Glens Falls Hospital IRB [Glens Falls / United States of America]
Banjaras Inc - Form 483, 2023-08-14
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Banjaras Inc [Sugar Land / United States of America]
Genentech, Inc. - EIR, 2023-09-01
$1190 - Available for instant download
Issued On: August, 2023
Inspection Type: EIR
Site Name: Genentech, Inc. [South San Francisco / 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]
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]
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]
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]
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]
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]
SOFIE Co. dba SOFIE - EIR, 2023-10-12
$1190 - Available for instant download
Issued On: August, 2023
Inspection Type: EIR
Site Name: SOFIE Co. dba SOFIE [Totowa / 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]
Henan Dongtai Pharm Co., Ltd. - EIR, 2024-01-17
$1190 - Available for instant download
Issued On: August, 2023
Inspection Type: EIR
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]
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]
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]
Synlait Milk Limited - EIR, 2023-11-14
$1190 - Available for instant download
Issued On: August, 2023
Inspection Type: EIR
Glenn Ward Dairy LLC - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Glenn Ward Dairy LLC [Burley / United States of America]
JJR GLOBAL INC. - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: JJR GLOBAL INC. [Stafford / 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]
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]
Micobe Inc - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
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]
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]
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]
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]
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]
Loren Yoder - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Loren Yoder [Belleville / 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]
Darrell Bartel - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
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]
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]
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]
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]
Cyclomedica Australia Pty Limited - Form 483, 2023-08-08
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Cyclomedica Australia Pty Limited [Sydney / Australia]
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]
Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) - Form 483, 2023-08-08
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) [Pingshan District / China]
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]
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]
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]
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]
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]
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]
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]
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]
Sri Krishna Pharmaceuticals Limited - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Sri Krishna Pharmaceuticals Limited [Hyderabad / 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]
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]
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]
Ethicon Endo-Surgery Inc - EIR, 2023-08-25
$1190 - Available for instant download
Issued On: August, 2023
Inspection Type: EIR
Site Name: Ethicon Endo-Surgery Inc [Blue Ash / 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]
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]
Oral Arts Dental Laboratories, Inc. - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Oral Arts Dental Laboratories, Inc. [Huntsville / United States of America]
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]
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]
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]
Inopak Ltd - Form 483, 2023-08-03
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
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]
Machado Dairy - Form 483, 2023-08-03
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Machado Dairy [Turlock / 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]
Felling, Bruce & Kelly - Form 483, 2023-08-03
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Felling, Bruce & Kelly [Belgrade / 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]
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]
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
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]
Grandview Dairy - Form 483, 2023-08-02
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Grandview Dairy [Le Grand / 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]
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]
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]