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Cardiovascular Systems Inc - Form 483R, 2014-11-26
$289 - Available for instant download
Issued On: October, 2014
Inspection Type: FDA 483 Response
Site Name: Cardiovascular Systems Inc [Saint Paul / United States of America]
Cardiovascular Systems Inc - Form 483, 2014-10-24
$289 - Available for instant download
Issued On: October, 2014
Inspection Type: FDA 483
Site Name: Cardiovascular Systems Inc [Saint Paul / United States of America]
ZACH SYSTEM S.A. - EIR, 2014-10-16
$1190 - Available for instant download
Issued On: October, 2014
Inspection Type: EIR
Site Name: ZACH SYSTEM S.A. [France / France]
Prosec Protection Systems, Inc. - Form 483, 2014-10-10
$289 - Available for instant download
Issued On: October, 2014
Inspection Type: FDA 483
Site Name: Prosec Protection Systems, Inc. [New Brunswick / United States of America]
Advanced Neuromodulation Systems, Inc- Sponsor - EIR, 2014-10-08
$1190 - Available for instant download
Issued On: October, 2014
Inspection Type: EIR
Site Name: Advanced Neuromodulation Systems, Inc- Sponsor [Plano / United States of America]
Reimers Systems, Inc. - Form 483, 2014-10-08
$289 - Available for instant download
Issued On: October, 2014
Inspection Type: FDA 483
Site Name: Reimers Systems, Inc. [Lorton / United States of America]
Oxysure Systems, Inc. - Form 483R, 2014-10-24
$289 - Available for instant download
Issued On: October, 2014
Inspection Type: FDA 483 Response
Site Name: Oxysure Systems, Inc. [Frisco / United States of America]
Oxysure Systems, Inc. - EIR, 2014-10-03
$1190 - Available for instant download
Issued On: October, 2014
Inspection Type: EIR
Site Name: Oxysure Systems, Inc. [Frisco / United States of America]
Oxysure Systems, Inc. - Form 483, 2014-10-03
$289 - Available for instant download
Issued On: October, 2014
Inspection Type: FDA 483
Site Name: Oxysure Systems, Inc. [Frisco / United States of America]
Criticare Systems (Malaysia) Sdn. Bhd. - Form 483, 2014-09-19
$289 - Available for instant download
Issued On: September, 2014
Inspection Type: FDA 483
Site Name: Criticare Systems (Malaysia) Sdn. Bhd. [Nusajaya / Malaysia]
Flier's Quality Water Systems, Inc. - Form 483, 2014-09-18
$289 - Available for instant download
Issued On: September, 2014
Inspection Type: FDA 483
Site Name: Flier's Quality Water Systems, Inc. [Byron Center / United States of America]
Merit Medical Systems, Inc. - Form 483, 2014-09-16
$289 - Available for instant download
Issued On: September, 2014
Inspection Type: FDA 483
Site Name: Merit Medical Systems, Inc. [Chester / United States of America]
International Medication Systems, Ltd. - Form 483, 2014-09-12
$289 - Available for instant download
Issued On: September, 2014
Inspection Type: FDA 483
Site Name: International Medication Systems, Ltd. [South El Monte / United States of America]
Keystone Laboratories, Inc. - Form 483R, 2014-10-21
$289 - Available for instant download
Issued On: September, 2014
Inspection Type: FDA 483 Response
Site Name: Keystone Laboratories, Inc. [Memphis / United States of America]
Keystone Laboratories, Inc. - Form 483, 2014-09-12
$289 - Available for instant download
Issued On: September, 2014
Inspection Type: FDA 483
Site Name: Keystone Laboratories, Inc. [Memphis / United States of America]
Odyssea Pharma SPRL - EIR, 2014-08-22
$1190 - Available for instant download
Issued On: August, 2014
Inspection Type: EIR
VA Northeast Ohio Healthcare System IRB - Form 483, 2014-07-10
$289 - Available for instant download
Issued On: July, 2014
Inspection Type: FDA 483
Site Name: VA Northeast Ohio Healthcare System IRB [Cleveland / United States of America]
Mdsysco LLC - Form 483, 2014-07-10
$289 - Available for instant download
Issued On: July, 2014
Inspection Type: FDA 483
NYSW Beverage Brands - Form 483, 2014-06-25
$289 - Available for instant download
Issued On: June, 2014
Inspection Type: FDA 483
Site Name: NYSW Beverage Brands [Fleischmanns / United States of America]
Theos Medical Systems, Inc. - Form 483, 2014-06-24
$289 - Available for instant download
Issued On: June, 2014
Inspection Type: FDA 483
Site Name: Theos Medical Systems, Inc. [Santa Clara / United States of America]
Topcon Medical Systems, Inc. - Form 483, 2014-06-16
$289 - Available for instant download
Issued On: June, 2014
Inspection Type: FDA 483
Site Name: Topcon Medical Systems, Inc. [Oakland / United States of America]
Tyson Foods, Inc. - Form 483, 2014-05-21
$289 - Available for instant download
Issued On: May, 2014
Inspection Type: FDA 483
Site Name: Tyson Foods, Inc. [Clearfield / United States of America]
Singing River Health System IRB - Form 483R, 2014-05-30
$289 - Available for instant download
Issued On: May, 2014
Inspection Type: FDA 483 Response
Site Name: Singing River Health System IRB [Pascagoula / United States of America]
Singing River Health System IRB - EIR, 2014-05-21
$1190 - Available for instant download
Issued On: May, 2014
Inspection Type: EIR
Site Name: Singing River Health System IRB [Pascagoula / United States of America]
Singing River Health System IRB - Form 483, 2014-05-21
$289 - Available for instant download
Issued On: May, 2014
Inspection Type: FDA 483
Site Name: Singing River Health System IRB [Pascagoula / United States of America]
Sebotek Hearing Systems, LLC - EIR, 2014-05-16
$1190 - Available for instant download
Issued On: May, 2014
Inspection Type: EIR
Site Name: Sebotek Hearing Systems, LLC [Tulsa / United States of America]
Meridian Medical Systems LLC - Form 483, 2014-05-15
$289 - Available for instant download
Issued On: May, 2014
Inspection Type: FDA 483
Site Name: Meridian Medical Systems LLC [Aurora / United States of America]
Diphasic Analyses Inc. dba Nutri-Spec - Form 483, 2014-04-24
$289 - Available for instant download
Issued On: April, 2014
Inspection Type: FDA 483
Site Name: Diphasic Analyses Inc. dba Nutri-Spec [Mifflintown / United States of America]
Aveva Drug Delivery Systems Inc. - Form 483, 2014-04-11
$289 - Available for instant download
Issued On: April, 2014
Inspection Type: FDA 483
Site Name: Aveva Drug Delivery Systems Inc. [Florida / United States of America]
Airways Development LLC - Form 483, 2014-04-09
$289 - Available for instant download
Issued On: April, 2014
Inspection Type: FDA 483
Site Name: Airways Development LLC [Kenilworth / United States of America]
Airways Development LLC - EIR, 2014-04-09
$1190 - Available for instant download
Issued On: April, 2014
Inspection Type: EIR
Site Name: Airways Development LLC [Kenilworth / United States of America]
Airways Development LLC - Form 483R, 2014-04-18
$289 - Available for instant download
Issued On: April, 2014
Inspection Type: FDA 483 Response
Site Name: Airways Development LLC [Kenilworth / United States of America]
American Contract Systems, Inc. - Form 483, 2014-04-03
$289 - Available for instant download
Issued On: April, 2014
Inspection Type: FDA 483
Site Name: American Contract Systems, Inc. [Waunakee / United States of America]
Keystone Industries - Form 483, 2014-04-03
$289 - Available for instant download
Issued On: April, 2014
Inspection Type: FDA 483
Site Name: Keystone Industries [Jersey / United States of America]
LTS Therapy Systems, LLC - Form 483, 2014-03-25
$289 - Available for instant download
Issued On: March, 2014
Inspection Type: FDA 483
Site Name: LTS Therapy Systems, LLC [West St. Paul / United States of America]
3T Medical Systems, LLC - Form 483, 2014-03-14
$289 - Available for instant download
Issued On: March, 2014
Inspection Type: FDA 483
Site Name: 3T Medical Systems, LLC [Livonia / United States of America]
M Dialysis AB - Form 483, 2014-03-13
$289 - Available for instant download
Issued On: March, 2014
Inspection Type: FDA 483
Site Name: M Dialysis AB [Stockholm / Sweden]
CORPAK MedSystems, Inc. - Form 483, 2014-03-07
$289 - Available for instant download
Issued On: March, 2014
Inspection Type: FDA 483
Site Name: CORPAK MedSystems, Inc. [Buffalo Grove / United States of America]
VMI Nutrition, Inc. dba Genysis Brand Solutions - Form 483, 2014-03-05
$289 - Available for instant download
Issued On: March, 2014
Inspection Type: FDA 483
Site Name: VMI Nutrition, Inc. dba Genysis Brand Solutions [Salt Lake City / United States of America]
GE Medical Systems, LLC - Form 483, 2014-02-28
$289 - Available for instant download
Issued On: February, 2014
Inspection Type: FDA 483
Site Name: GE Medical Systems, LLC [Waukesha / United States of America]
GE Medical Systems, LLC - EIR, 2014-02-28
$1190 - Available for instant download
Issued On: February, 2014
Inspection Type: EIR
Site Name: GE Medical Systems, LLC [Waukesha / United States of America]
American Medical Systems, LLC - Form 483, 2014-02-24
$289 - Available for instant download
Issued On: February, 2014
Inspection Type: FDA 483
Site Name: American Medical Systems, LLC [Minnetonka / United States of America]
American Medical Systems, LLC - Form 483R, 2014-02-24
$289 - Available for instant download
Issued On: February, 2014
Inspection Type: FDA 483 Response
Site Name: American Medical Systems, LLC [Minnetonka / United States of America]
BayCare Health Systems IRB - EIR, 2014-02-19
$1190 - Available for instant download
Issued On: February, 2014
Inspection Type: EIR
Site Name: BayCare Health Systems IRB [Tampa / United States of America]
Terumo Cardiovascular Systems Corporation - Form 483, 2014-02-17
$289 - Available for instant download
Issued On: February, 2014
Inspection Type: FDA 483
Site Name: Terumo Cardiovascular Systems Corporation [Ann Arbor / United States of America]
Shimadzu Medical Systems - EIR, 2014-02-13
$1190 - Available for instant download
Issued On: February, 2014
Inspection Type: EIR
Site Name: Shimadzu Medical Systems [Torrance / United States of America]
Rowny Systems, Inc. - Form 483, 2014-02-10
$289 - Available for instant download
Issued On: February, 2014
Inspection Type: FDA 483
Site Name: Rowny Systems, Inc. [Cabin John / United States of America]
Philips Medical Systems (Cleveland) Inc - Form 483, 2014-01-28
$289 - Available for instant download
Issued On: January, 2014
Inspection Type: FDA 483
Site Name: Philips Medical Systems (Cleveland) Inc [Cleveland / United States of America]
Philips Medical Systems (Cleveland) Inc - EIR, 2014-01-28
$1190 - Available for instant download
Issued On: January, 2014
Inspection Type: EIR
Site Name: Philips Medical Systems (Cleveland) Inc [Cleveland / United States of America]
Sparton Medical Systems Colorado - Form 483, 2014-01-24
$289 - Available for instant download
Issued On: January, 2014
Inspection Type: FDA 483
Site Name: Sparton Medical Systems Colorado [Frederick / United States of America]
Physio-Control, Inc. - Form 483, 2014-01-17
$289 - Available for instant download
Issued On: January, 2014
Inspection Type: FDA 483
Site Name: Physio-Control, Inc. [Redmond / United States of America]
Fujifilm Medical Systems U.S.A., Inc. - Form 483, 2014-01-16
$289 - Available for instant download
Issued On: January, 2014
Inspection Type: FDA 483
Site Name: Fujifilm Medical Systems U.S.A., Inc. [Wayne / United States of America]
Enhanced Medical Systems LLC - Form 483, 2014-01-06
$289 - Available for instant download
Issued On: January, 2014
Inspection Type: FDA 483
Site Name: Enhanced Medical Systems LLC [Brentwood / United States of America]
Analytical Control Systems, Inc - Form 483, 2013-12-03
$289 - Available for instant download
Issued On: December, 2013
Inspection Type: FDA 483
Site Name: Analytical Control Systems, Inc [Fishers / United States of America]
Fujifilm Medical Systems USA, Inc. - Form 483, 2013-11-22
$289 - Available for instant download
Issued On: November, 2013
Inspection Type: FDA 483
Site Name: Fujifilm Medical Systems USA, Inc. [Indianapolis / United States of America]
General Physiotherapy Inc - Form 483, 2013-11-07
$289 - Available for instant download
Issued On: November, 2013
Inspection Type: FDA 483
Site Name: General Physiotherapy Inc [Earth City / United States of America]
Freeland Systems, LLC - Form 483, 2013-11-04
$289 - Available for instant download
Issued On: November, 2013
Inspection Type: FDA 483
Site Name: Freeland Systems, LLC [Westminster / United States of America]
Mindways Software, Inc. - Form 483, 2013-10-24
$289 - Available for instant download
Issued On: October, 2013
Inspection Type: FDA 483
Site Name: Mindways Software, Inc. [Austin / United States of America]
GE Medical Systems Information Technologies, Inc. - Form 483, 2013-09-25
$289 - Available for instant download
Issued On: September, 2013
Inspection Type: FDA 483
Site Name: GE Medical Systems Information Technologies, Inc. [Milwaukee / United States of America]
U-systems Inc - Form 483, 2013-09-10
$289 - Available for instant download
Issued On: September, 2013
Inspection Type: FDA 483
Site Name: U-systems Inc [Sunnyvale / United States of America]
Cheese Factory Eyssen B.V. - Form 483, 2013-08-27
$289 - Available for instant download
Issued On: August, 2013
Inspection Type: FDA 483
Site Name: Cheese Factory Eyssen B.V. [Oosthuizen / Netherlands]
Crystal Reflections Int Inc - Form 483, 2013-08-20
$289 - Available for instant download
Issued On: August, 2013
Inspection Type: FDA 483
Site Name: Crystal Reflections Int Inc [Green Valley / United States of America]
Keystone Laboratories, Inc. - Form 483, 2013-08-15
$289 - Available for instant download
Issued On: August, 2013
Inspection Type: FDA 483
Site Name: Keystone Laboratories, Inc. [Memphis / United States of America]
Keystone Laboratories, Inc. - Form 483R, 2013-09-15
$289 - Available for instant download
Issued On: August, 2013
Inspection Type: FDA 483 Response
Site Name: Keystone Laboratories, Inc. [Memphis / United States of America]
King Systems Corp. dba Ambu, Inc. - Form 483, 2013-08-14
$289 - Available for instant download
Issued On: August, 2013
Inspection Type: FDA 483
Site Name: King Systems Corp. dba Ambu, Inc. [Noblesville / United States of America]
Prosec Protection Systems, Inc. - Form 483, 2013-08-02
$289 - Available for instant download
Issued On: August, 2013
Inspection Type: FDA 483
Site Name: Prosec Protection Systems, Inc. [New Brunswick / United States of America]
Philips and Neusoft Medical Systems Co., Ltd. - Form 483, 2013-08-02
$289 - Available for instant download
Issued On: August, 2013
Inspection Type: FDA 483
Site Name: Philips and Neusoft Medical Systems Co., Ltd. [Sujiatun Shenyang / China]
GE Medical Systems, LLC - Form 483, 2013-07-31
$289 - Available for instant download
Issued On: July, 2013
Inspection Type: FDA 483
Site Name: GE Medical Systems, LLC [Waukesha / United States of America]
Mark Woyshville, M.D. - EIR, 2013-07-11
$1190 - Available for instant download
Issued On: July, 2013
Inspection Type: EIR
Site Name: Mark Woyshville, M.D. [Middleburg Heights / United States of America]
Mark Woyshville, M.D. - Form 483, 2013-07-11
$289 - Available for instant download
Issued On: July, 2013
Inspection Type: FDA 483
Site Name: Mark Woyshville, M.D. [Middleburg Heights / United States of America]
Topcon Medical Laser Systems, Inc. - Form 483, 2013-07-10
$289 - Available for instant download
Issued On: July, 2013
Inspection Type: FDA 483
Site Name: Topcon Medical Laser Systems, Inc. [Livermore / United States of America]
Lifesaving Systems Corporation - Form 483, 2013-07-09
$289 - Available for instant download
Issued On: July, 2013
Inspection Type: FDA 483
Site Name: Lifesaving Systems Corporation [Apollo Beach / United States of America]
Draeger Medical Systems, Inc. - Form 483, 2013-07-03
$289 - Available for instant download
Issued On: July, 2013
Inspection Type: FDA 483
Site Name: Draeger Medical Systems, Inc. [Telford / United States of America]
Healthcare Management Systems Inc - Form 483, 2013-07-03
$289 - Available for instant download
Issued On: July, 2013
Inspection Type: FDA 483
Site Name: Healthcare Management Systems Inc [Franklin / United States of America]
Genesis Biosystems, Inc - Form 483, 2013-06-27
$289 - Available for instant download
Issued On: June, 2013
Inspection Type: FDA 483
Site Name: Genesis Biosystems, Inc [Lewisville / United States of America]
Biodex Medical Systems, Inc. - Form 483, 2013-06-20
$289 - Available for instant download
Issued On: June, 2013
Inspection Type: FDA 483
Site Name: Biodex Medical Systems, Inc. [Shirley / United States of America]
Delsys, Incorporated - Form 483, 2013-06-18
$289 - Available for instant download
Issued On: June, 2013
Inspection Type: FDA 483
Site Name: Delsys, Incorporated [Natick / United States of America]
NATURES WAY PURE WATER SYSTEMS INC - EIR, 2013-06-18
$1190 - Available for instant download
Issued On: June, 2013
Inspection Type: EIR
Site Name: NATURES WAY PURE WATER SYSTEMS INC [Pittston / United States of America]
International Medication Systems, Ltd. - Form 483, 2013-06-17
$289 - Available for instant download
Issued On: June, 2013
Inspection Type: FDA 483
Site Name: International Medication Systems, Ltd. [South El Monte / United States of America]
Cardiovascular Systems, Inc. - Form 483, 2013-06-14
$289 - Available for instant download
Issued On: June, 2013
Inspection Type: FDA 483
Site Name: Cardiovascular Systems, Inc. [Houston / United States of America]
Vicon Motion Systems, Inc. - Form 483, 2013-06-11
$289 - Available for instant download
Issued On: June, 2013
Inspection Type: FDA 483
Site Name: Vicon Motion Systems, Inc. [Centennial / United States of America]
Motion Analysis Corporation - Form 483, 2013-06-06
$289 - Available for instant download
Issued On: June, 2013
Inspection Type: FDA 483
Site Name: Motion Analysis Corporation [Santa Rosa / United States of America]
SystemsOne, LLC - Form 483, 2013-06-05
$289 - Available for instant download
Issued On: June, 2013
Inspection Type: FDA 483
Site Name: SystemsOne, LLC [Stuart / United States of America]
Genesys Orthopedics Systems, LLC - Form 483, 2013-06-05
$289 - Available for instant download
Issued On: June, 2013
Inspection Type: FDA 483
Site Name: Genesys Orthopedics Systems, LLC [Bldg # 3 West Lake Hills / United States of America]
Meridian Medical Systems LLC - Form 483, 2013-05-31
$289 - Available for instant download
Issued On: May, 2013
Inspection Type: FDA 483
Site Name: Meridian Medical Systems LLC [Aurora / United States of America]
Extended Care Air Therapy Systems Inc - Form 483, 2013-05-30
$289 - Available for instant download
Issued On: May, 2013
Inspection Type: FDA 483
Site Name: Extended Care Air Therapy Systems Inc [Roseville / United States of America]
Robert Bosch Heathcare Systems Inc - Form 483, 2013-05-22
$289 - Available for instant download
Issued On: May, 2013
Inspection Type: FDA 483
Site Name: Robert Bosch Heathcare Systems Inc [Utica / United States of America]
Henry Ford Health System Institutional Review Board - EIR, 2013-05-15
$1190 - Available for instant download
Issued On: May, 2013
Inspection Type: EIR
Site Name: Henry Ford Health System Institutional Review Board [Detroit / United States of America]
GE Medical Systems Information Technologies - Form 483, 2013-05-14
$289 - Available for instant download
Issued On: May, 2013
Inspection Type: FDA 483
Site Name: GE Medical Systems Information Technologies [El Paso / United States of America]
Draeger Medical Systems, Inc. - Form 483, 2013-04-12
$289 - Available for instant download
Issued On: April, 2013
Inspection Type: FDA 483
Site Name: Draeger Medical Systems, Inc. [Andover / United States of America]
Hitachi Medical Systems America Inc - Form 483, 2013-04-08
$289 - Available for instant download
Issued On: April, 2013
Inspection Type: FDA 483
Site Name: Hitachi Medical Systems America Inc [Twinsburg / United States of America]
VMI Nutrition, Inc. dba Genysis Brand Solutions - Form 483, 2013-04-08
$289 - Available for instant download
Issued On: April, 2013
Inspection Type: FDA 483
Site Name: VMI Nutrition, Inc. dba Genysis Brand Solutions [Salt Lake City / United States of America]
Engineered Medical Systems,Inc - Form 483, 2013-03-22
$289 - Available for instant download
Issued On: March, 2013
Inspection Type: FDA 483
Site Name: Engineered Medical Systems,Inc [Indianapolis / United States of America]
Transonic Systems Inc - Form 483, 2013-03-21
$289 - Available for instant download
Issued On: March, 2013
Inspection Type: FDA 483
Site Name: Transonic Systems Inc [Ithaca / United States of America]
ALPINION MEDICAL SYSTEMS CO. LTD - Form 483, 2013-03-15
$289 - Available for instant download
Issued On: March, 2013
Inspection Type: FDA 483
TrueVision Systems Inc - EIR, 2013-03-12
$1190 - Available for instant download
Issued On: March, 2013
Inspection Type: EIR
Site Name: TrueVision Systems Inc [Goleta / United States of America]
Graftys, S.A. - Form 483, 2013-03-07
$289 - Available for instant download
Issued On: March, 2013
Inspection Type: FDA 483
Site Name: Graftys, S.A. [Aix En Provence / France]
Delcath Systems Inc. - Form 483, 2013-02-15
$289 - Available for instant download
Issued On: February, 2013
Inspection Type: FDA 483
Site Name: Delcath Systems Inc. [Queensbury / United States of America]
Oleksandra Stasyshyn, MD, PhD - Form 483, 2013-01-25
$289 - Available for instant download
Issued On: January, 2013
Inspection Type: FDA 483
Oleksandra Stasyshyn, MD, PhD - EIR, 2013-01-25
$1190 - Available for instant download
Issued On: January, 2013
Inspection Type: EIR