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Physician's Technology, Llc - Form 483, 2016-06-24
$289 - Available for instant download
Issued On: June, 2016
Inspection Type: FDA 483
Site Name: Physician's Technology, Llc [Monroe / United States of America]
Merit Medical Systems Inc - EIR, 2016-06-23
$1190 - Available for instant download
Issued On: June, 2016
Inspection Type: EIR
Site Name: Merit Medical Systems Inc [Malvern / United States of America]
Leica Microsystems (Schweiz) Ag - Form 483, 2016-06-16
$289 - Available for instant download
Issued On: June, 2016
Inspection Type: FDA 483
Site Name: Leica Microsystems (Schweiz) Ag [Heerbrugg / Switzerland]
Respiratory Delivery Systems - Form 483, 2016-06-16
$289 - Available for instant download
Issued On: June, 2016
Inspection Type: FDA 483
Site Name: Respiratory Delivery Systems [Chelmsford / United States of America]
Blood Bank Computer Systems, Inc. - Form 483, 2016-06-16
$289 - Available for instant download
Issued On: June, 2016
Inspection Type: FDA 483
Site Name: Blood Bank Computer Systems, Inc. [Bonney Lake / United States of America]
Shionogi Analysis Center Co., Ltd. - Form 483, 2016-06-03
$289 - Available for instant download
Issued On: June, 2016
Inspection Type: FDA 483
Site Name: Shionogi Analysis Center Co., Ltd. [Amagasaki / Japan]
CAS Medical Systems, Inc. - Form 483, 2016-04-22
$289 - Available for instant download
Issued On: April, 2016
Inspection Type: FDA 483
Site Name: CAS Medical Systems, Inc. [Branford / United States of America]
Angiodynamics Inc. (Navilyst Medical Inc.) - Form 483, 2016-04-15
$289 - Available for instant download
Issued On: April, 2016
Inspection Type: FDA 483
Site Name: Angiodynamics Inc. (Navilyst Medical Inc.) [Glens Falls / United States of America]
Keystone Industries - Form 483, 2016-04-05
$289 - Available for instant download
Issued On: April, 2016
Inspection Type: FDA 483
Site Name: Keystone Industries [Jersey / United States of America]
GelCool Systems, Inc - Form 483, 2016-03-07
$289 - Available for instant download
Issued On: March, 2016
Inspection Type: FDA 483
Site Name: GelCool Systems, Inc [Franklin / United States of America]
Analytical Control Systems, Inc - EIR, 2016-02-29
$1190 - Available for instant download
Issued On: February, 2016
Inspection Type: EIR
Site Name: Analytical Control Systems, Inc [Fishers / United States of America]
Analytical Control Systems, Inc - Form 483, 2016-02-29
$289 - Available for instant download
Issued On: February, 2016
Inspection Type: FDA 483
Site Name: Analytical Control Systems, Inc [Fishers / United States of America]
Analytical Control Systems, Inc - Form 483R, 2016-03-16
$289 - Available for instant download
Issued On: February, 2016
Inspection Type: FDA 483 Response
Site Name: Analytical Control Systems, Inc [Fishers / United States of America]
Integrated Medical Systems International Inc. - EIR, 2016-02-25
$1190 - Available for instant download
Issued On: February, 2016
Inspection Type: EIR
Site Name: Integrated Medical Systems International Inc. [Hillsborough / United States of America]
Jeffreys Drug Store - Form 483, 2016-02-09
$289 - Available for instant download
Issued On: February, 2016
Inspection Type: FDA 483
Site Name: Jeffreys Drug Store [Canonsburg / United States of America]
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - Form 483, 2016-02-05
$289 - Available for instant download
Issued On: February, 2016
Inspection Type: FDA 483
Site Name: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. [Best / Netherlands]
Keystone Laboratories, Inc. - Form 483, 2016-02-05
$289 - Available for instant download
Issued On: February, 2016
Inspection Type: FDA 483
Site Name: Keystone Laboratories, Inc. [Memphis / United States of America]
Keystone Laboratories, Inc. - Form 483R, 2016-02-08
$289 - Available for instant download
Issued On: February, 2016
Inspection Type: FDA 483 Response
Site Name: Keystone Laboratories, Inc. [Memphis / United States of America]
Philips and Neusoft Medical Systems Co., Ltd. - Form 483, 2016-02-04
$289 - Available for instant download
Issued On: February, 2016
Inspection Type: FDA 483
Site Name: Philips and Neusoft Medical Systems Co., Ltd. [Sujiatun Shenyang / China]
Mercy Health System IRB - Form 483R, 2016-02-10
$289 - Available for instant download
Issued On: February, 2016
Inspection Type: FDA 483 Response
Site Name: Mercy Health System IRB [Janesville / United States of America]
Mercy Health System IRB - Form 483, 2016-02-01
$289 - Available for instant download
Issued On: February, 2016
Inspection Type: FDA 483
Site Name: Mercy Health System IRB [Janesville / United States of America]
Staubach Barror Water Systems Inc., DBA Aqua Pure - Form 483, 2016-01-08
$289 - Available for instant download
Issued On: January, 2016
Inspection Type: FDA 483
Site Name: Staubach Barror Water Systems Inc., DBA Aqua Pure [Schenectady / United States of America]
Nova Health Systems Inc - Form 483, 2016-01-05
$289 - Available for instant download
Issued On: January, 2016
Inspection Type: FDA 483
Site Name: Nova Health Systems Inc [Utica / United States of America]
INSYS MANUFACTURING, LLC - Form 483, 2015-12-14
$289 - Available for instant download
Issued On: December, 2015
Inspection Type: FDA 483
Site Name: INSYS MANUFACTURING, LLC [Round Rock / United States of America]
YS Life Science Co., Ltd. - Form 483, 2015-12-11
$289 - Available for instant download
Issued On: December, 2015
Inspection Type: FDA 483
Site Name: YS Life Science Co., Ltd. [Korea South / Korea (Republic of)]
Criticare Systems, Inc. through Water Tower Capital, LLC - Form 483, 2015-11-20
$289 - Available for instant download
Issued On: November, 2015
Inspection Type: FDA 483
Site Name: Criticare Systems, Inc. through Water Tower Capital, LLC [Waukesha / United States of America]
Custom Foam Systems Ltd. - Form 483, 2015-11-19
$289 - Available for instant download
Issued On: November, 2015
Inspection Type: FDA 483
Medical Measurement Systems B.V. - Form 483, 2015-11-19
$289 - Available for instant download
Issued On: November, 2015
Inspection Type: FDA 483
Site Name: Medical Measurement Systems B.V. [Enschede / Netherlands]
Crystal Claire Cosmetics Inc. - Form 483, 2015-11-06
$289 - Available for instant download
Issued On: November, 2015
Inspection Type: FDA 483
Site Name: Crystal Claire Cosmetics Inc. [Scarborough / Canada]
Diopsys, Inc. - Form 483, 2015-11-02
$289 - Available for instant download
Issued On: November, 2015
Inspection Type: FDA 483
Site Name: Diopsys, Inc. [Pine Brook / United States of America]
Oxysure Systems, Inc. - Form 483, 2015-09-28
$289 - Available for instant download
Issued On: September, 2015
Inspection Type: FDA 483
Site Name: Oxysure Systems, Inc. [Frisco / United States of America]
Cardiovascular Systems Inc - EIR, 2015-09-25
$1190 - Available for instant download
Issued On: September, 2015
Inspection Type: EIR
Site Name: Cardiovascular Systems Inc [Saint Paul / United States of America]
Performance Health Systems LLC - EIR, 2015-09-24
$1190 - Available for instant download
Issued On: September, 2015
Inspection Type: EIR
Site Name: Performance Health Systems LLC [Northbrook / United States of America]
Performance Health Systems LLC - Form 483, 2015-09-24
$289 - Available for instant download
Issued On: September, 2015
Inspection Type: FDA 483
Site Name: Performance Health Systems LLC [Northbrook / United States of America]
CrystalBraces, LLC. - Form 483, 2015-09-23
$289 - Available for instant download
Issued On: September, 2015
Inspection Type: FDA 483
Site Name: CrystalBraces, LLC. [Dallas / United States of America]
WiseWays Herbals, LLC - Form 483, 2015-09-17
$289 - Available for instant download
Issued On: September, 2015
Inspection Type: FDA 483
Site Name: WiseWays Herbals, LLC [Worthington / United States of America]
HYSAN PHARMACEUTICAL COMPANY LIMITED - Form 483, 2015-09-10
$289 - Available for instant download
Issued On: September, 2015
Inspection Type: FDA 483
Site Name: HYSAN PHARMACEUTICAL COMPANY LIMITED [Hong Kong / Hong Kong]
Omega Laser Systems - Form 483, 2015-09-10
$289 - Available for instant download
Issued On: September, 2015
Inspection Type: FDA 483
Site Name: Omega Laser Systems [Halstead / United Kingdom of Great Britain and Northern Ireland]
American Contract Systems, Inc. - Form 483, 2015-09-04
$289 - Available for instant download
Issued On: September, 2015
Inspection Type: FDA 483
Site Name: American Contract Systems, Inc. [Temple Terrace / United States of America]
O.M. Performance, Inc. DBA PerSys Medical - Form 483, 2015-08-27
$289 - Available for instant download
Issued On: August, 2015
Inspection Type: FDA 483
Site Name: O.M. Performance, Inc. DBA PerSys Medical [Houston / United States of America]
International Medication Systems, Ltd. - Form 483, 2015-08-10
$289 - Available for instant download
Issued On: August, 2015
Inspection Type: FDA 483
Site Name: International Medication Systems, Ltd. [South El Monte / United States of America]
Parkview Health Systems Inc. IRB - EIR, 2015-07-27
$1190 - Available for instant download
Issued On: July, 2015
Inspection Type: EIR
Site Name: Parkview Health Systems Inc. IRB [Fort Wayne / United States of America]
ImClone Systems LLC - EIR, 2015-07-10
$1190 - Available for instant download
Issued On: July, 2015
Inspection Type: EIR
Site Name: ImClone Systems LLC [Jersey / United States of America]
Affinity Health System, Inc. (IRB) - EIR, 2015-07-08
$1190 - Available for instant download
Issued On: July, 2015
Inspection Type: EIR
Site Name: Affinity Health System, Inc. (IRB) [Appleton / United States of America]
Affinity Health System, Inc. (IRB) - Form 483R, 2015-07-30
$289 - Available for instant download
Issued On: July, 2015
Inspection Type: FDA 483 Response
Site Name: Affinity Health System, Inc. (IRB) [Appleton / United States of America]
Affinity Health System, Inc. (IRB) - Form 483, 2015-07-08
$289 - Available for instant download
Issued On: July, 2015
Inspection Type: FDA 483
Site Name: Affinity Health System, Inc. (IRB) [Appleton / United States of America]
Physio-Control, Inc. - Form 483, 2015-06-26
$289 - Available for instant download
Issued On: June, 2015
Inspection Type: FDA 483
Site Name: Physio-Control, Inc. [Redmond / United States of America]
Physio-Control, Inc. - Form 483R, 2015-07-20
$289 - Available for instant download
Issued On: June, 2015
Inspection Type: FDA 483 Response
Site Name: Physio-Control, Inc. [Redmond / United States of America]
Repro-Med Systems, Inc. - Form 483, 2015-06-23
$289 - Available for instant download
Issued On: June, 2015
Inspection Type: FDA 483
Site Name: Repro-Med Systems, Inc. [Chester / United States of America]
Ondal Medical Systems of America, Inc. - Form 483, 2015-06-22
$289 - Available for instant download
Issued On: June, 2015
Inspection Type: FDA 483
Site Name: Ondal Medical Systems of America, Inc. [Sandston / United States of America]
AngioSystems Inc - Form 483, 2015-06-18
$289 - Available for instant download
Issued On: June, 2015
Inspection Type: FDA 483
Site Name: AngioSystems Inc [Ducktown / United States of America]
Forte Automation Systems Inc - Form 483, 2015-06-10
$289 - Available for instant download
Issued On: June, 2015
Inspection Type: FDA 483
Site Name: Forte Automation Systems Inc [Machesney Park / United States of America]
The University of Kansas Health System - Form 483, 2015-05-05
$289 - Available for instant download
Issued On: May, 2015
Inspection Type: FDA 483
Site Name: The University of Kansas Health System [Kansas City / United States of America]
Polysciences, Inc. - Form 483, 2015-04-29
$289 - Available for instant download
Issued On: April, 2015
Inspection Type: FDA 483
Site Name: Polysciences, Inc. [Warrington / United States of America]
Dysal S.A. de C.V. - Form 483, 2015-04-28
$289 - Available for instant download
Issued On: April, 2015
Inspection Type: FDA 483
Site Name: Dysal S.A. de C.V. [Huixquilucan / -]
King Systems Corp. dba Ambu, Inc. - Form 483, 2015-04-24
$289 - Available for instant download
Issued On: April, 2015
Inspection Type: FDA 483
Site Name: King Systems Corp. dba Ambu, Inc. [Noblesville / United States of America]
Olympus Medical Systems Corporation - EIR, 2015-04-24
$1190 - Available for instant download
Issued On: April, 2015
Inspection Type: EIR
Site Name: Olympus Medical Systems Corporation [Hachioji / Japan]
Olympus Medical Systems Corporation - Form 483, 2015-04-24
$289 - Available for instant download
Issued On: April, 2015
Inspection Type: FDA 483
Site Name: Olympus Medical Systems Corporation [Hachioji / Japan]
Osseus Fusion Systems, LLC - Form 483R, 2015-05-06
$289 - Available for instant download
Issued On: April, 2015
Inspection Type: FDA 483 Response
Site Name: Osseus Fusion Systems, LLC [Dallas / United States of America]
Osseus Fusion Systems, LLC - Form 483, 2015-04-23
$289 - Available for instant download
Issued On: April, 2015
Inspection Type: FDA 483
Site Name: Osseus Fusion Systems, LLC [Dallas / United States of America]
SynCardia Systems LLC - Form 483, 2015-04-17
$289 - Available for instant download
Issued On: April, 2015
Inspection Type: FDA 483
Site Name: SynCardia Systems LLC [Tucson / United States of America]
Fujifilm Medical Systems U.S.A., Inc. - Form 483, 2015-04-20
$289 - Available for instant download
Issued On: April, 2015
Inspection Type: FDA 483
Site Name: Fujifilm Medical Systems U.S.A., Inc. [Wayne / United States of America]
Organ Recovery Systems, Inc. - Form 483, 2015-05-19
$289 - Available for instant download
Issued On: April, 2015
Inspection Type: FDA 483
Site Name: Organ Recovery Systems, Inc. [Itasca / United States of America]
Organ Recovery Systems, Inc. - Form 483R, 2015-04-23
$289 - Available for instant download
Issued On: April, 2015
Inspection Type: FDA 483 Response
Site Name: Organ Recovery Systems, Inc. [Itasca / United States of America]
American Medical Systems Innovations - Form 483, 2015-04-03
$289 - Available for instant download
Issued On: April, 2015
Inspection Type: FDA 483
Site Name: American Medical Systems Innovations [San Jose / United States of America]
Biomedical Systems Corp - EIR, 2015-03-26
$1190 - Available for instant download
Issued On: March, 2015
Inspection Type: EIR
Site Name: Biomedical Systems Corp [Maryland Heights / United States of America]
GE OEC Medical Systems, Inc - Form 483, 2015-03-25
$289 - Available for instant download
Issued On: March, 2015
Inspection Type: FDA 483
Site Name: GE OEC Medical Systems, Inc [Salt Lake City / United States of America]
Dream Systems, LLC - Form 483, 2015-03-20
$289 - Available for instant download
Issued On: March, 2015
Inspection Type: FDA 483
Site Name: Dream Systems, LLC [Roseville / United States of America]
Biodex Medical Systems, Inc. - Form 483, 2015-03-18
$289 - Available for instant download
Issued On: March, 2015
Inspection Type: FDA 483
Site Name: Biodex Medical Systems, Inc. [Shirley / United States of America]
Mevion Medical Systems, Inc. - Form 483, 2015-03-16
$289 - Available for instant download
Issued On: March, 2015
Inspection Type: FDA 483
Site Name: Mevion Medical Systems, Inc. [Littleton / United States of America]
Keystone Laboratories, Inc. - Form 483, 2015-03-13
$289 - Available for instant download
Issued On: March, 2015
Inspection Type: FDA 483
Site Name: Keystone Laboratories, Inc. [Memphis / United States of America]
CONTEC MEDICAL SYSTEMS CO., LTD - Form 483, 2015-03-05
$289 - Available for instant download
Issued On: March, 2015
Inspection Type: FDA 483
Site Name: CONTEC MEDICAL SYSTEMS CO., LTD [Qinhuangdao / China]
Aesculap Implant Systems LLC - Form 483, 2015-03-04
$289 - Available for instant download
Issued On: March, 2015
Inspection Type: FDA 483
Site Name: Aesculap Implant Systems LLC [Breinigsville / United States of America]
Prosec Protection Systems, Inc. - Form 483, 2015-02-25
$289 - Available for instant download
Issued On: February, 2015
Inspection Type: FDA 483
Site Name: Prosec Protection Systems, Inc. [New Brunswick / United States of America]
Vascular Pathways, Inc - Form 483, 2015-02-25
$289 - Available for instant download
Issued On: February, 2015
Inspection Type: FDA 483
Site Name: Vascular Pathways, Inc [Boca Raton / United States of America]
Physician Preferred Medical, LLC - Form 483, 2015-02-19
$289 - Available for instant download
Issued On: February, 2015
Inspection Type: FDA 483
Site Name: Physician Preferred Medical, LLC [Oklahoma City / United States of America]
Lusys Laboratories, Inc. - Form 483, 2015-02-19
$289 - Available for instant download
Issued On: February, 2015
Inspection Type: FDA 483
Site Name: Lusys Laboratories, Inc. [San Diego / United States of America]
Dm Systems Beijing Co Ltd - Form 483, 2015-02-10
$289 - Available for instant download
Issued On: February, 2015
Inspection Type: FDA 483
Site Name: Dm Systems Beijing Co Ltd [Beijing / China]
Neurowave Systems Inc - Form 483, 2015-02-03
$289 - Available for instant download
Issued On: February, 2015
Inspection Type: FDA 483
Site Name: Neurowave Systems Inc [Cleveland Heights / United States of America]
Becton Dickinson Medical Systems - EIR, 2015-01-23
$1190 - Available for instant download
Issued On: January, 2015
Inspection Type: EIR
Site Name: Becton Dickinson Medical Systems [Canaan / United States of America]
Advanced Physician Solutions, Inc. - Form 483, 2015-01-16
$289 - Available for instant download
Issued On: January, 2015
Inspection Type: FDA 483
Site Name: Advanced Physician Solutions, Inc. [N Hollywood / United States of America]
Integrated Medical Systems International Inc. - Form 483, 2015-01-14
$289 - Available for instant download
Issued On: January, 2015
Inspection Type: FDA 483
Site Name: Integrated Medical Systems International Inc. [Stow / United States of America]
St. John Health System IRB - Form 483, 2015-01-09
$289 - Available for instant download
Issued On: January, 2015
Inspection Type: FDA 483
Site Name: St. John Health System IRB [Tulsa / United States of America]
St. John Health System IRB - EIR, 2015-01-09
$1190 - Available for instant download
Issued On: January, 2015
Inspection Type: EIR
Site Name: St. John Health System IRB [Tulsa / United States of America]
PRN Physician Recommended Nutriceuticals - Form 483, 2015-01-05
$289 - Available for instant download
Issued On: January, 2015
Inspection Type: FDA 483
Site Name: PRN Physician Recommended Nutriceuticals [Blue Bell / United States of America]
Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy - Form 483, 2014-12-22
$289 - Available for instant download
Issued On: December, 2014
Inspection Type: FDA 483
Site Name: Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy [Fort Myers / United States of America]
Genesis Biosystems, Inc - EIR, 2014-12-16
$1190 - Available for instant download
Issued On: December, 2014
Inspection Type: EIR
Site Name: Genesis Biosystems, Inc [Lewisville / United States of America]
Genesis Biosystems, Inc - Form 483R, 2015-01-05
$289 - Available for instant download
Issued On: December, 2014
Inspection Type: FDA 483 Response
Site Name: Genesis Biosystems, Inc [Lewisville / United States of America]
Genesis Biosystems, Inc - Form 483, 2014-12-16
$289 - Available for instant download
Issued On: December, 2014
Inspection Type: FDA 483
Site Name: Genesis Biosystems, Inc [Lewisville / United States of America]
Better Health Systems, Inc - EIR, 2014-12-12
$1190 - Available for instant download
Issued On: December, 2014
Inspection Type: EIR
Site Name: Better Health Systems, Inc [Monument / United States of America]
Epic Systems Corporation - EIR, 2014-12-12
$1190 - Available for instant download
Issued On: December, 2014
Inspection Type: EIR
Site Name: Epic Systems Corporation [Verona / United States of America]
Cardiovascular Systems, Inc. - Form 483, 2014-12-12
$289 - Available for instant download
Issued On: December, 2014
Inspection Type: FDA 483
Site Name: Cardiovascular Systems, Inc. [Houston / United States of America]
Epic Systems Corporation - Form 483, 2014-12-12
$289 - Available for instant download
Issued On: December, 2014
Inspection Type: FDA 483
Site Name: Epic Systems Corporation [Verona / United States of America]
Better Health Systems, Inc - Form 483, 2014-12-12
$289 - Available for instant download
Issued On: December, 2014
Inspection Type: FDA 483
Site Name: Better Health Systems, Inc [Monument / United States of America]
NATURES WAY PURE WATER SYSTEMS INC - EIR, 2014-11-25
$1190 - Available for instant download
Issued On: November, 2014
Inspection Type: EIR
Site Name: NATURES WAY PURE WATER SYSTEMS INC [Pittston / United States of America]
Physician Software Systems LLC - Form 483, 2014-11-24
$289 - Available for instant download
Issued On: November, 2014
Inspection Type: FDA 483
Site Name: Physician Software Systems LLC [Lisle / United States of America]
Ra Medical Systems, Inc. - Form 483, 2014-11-05
$289 - Available for instant download
Issued On: November, 2014
Inspection Type: FDA 483
Site Name: Ra Medical Systems, Inc. [Carlsbad / United States of America]
Neil's Toys & Novelties, Inc. - Form 483, 2014-10-31
$289 - Available for instant download
Issued On: October, 2014
Inspection Type: FDA 483
Site Name: Neil's Toys & Novelties, Inc. [Roanoke / United States of America]
Summa Health System IRB - EIR, 2014-10-31
$1190 - Available for instant download
Issued On: October, 2014
Inspection Type: EIR
Site Name: Summa Health System IRB [Akron / United States of America]
Cardiovascular Systems Inc - EIR, 2014-10-24
$1190 - Available for instant download
Issued On: October, 2014
Inspection Type: EIR
Site Name: Cardiovascular Systems Inc [Saint Paul / United States of America]