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Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. - Form 483, 2018-05-21
$289 - Available for instant download
Issued On: May, 2018
Inspection Type: FDA 483
Site Name: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. [Dover / United States of America]
Lusys Laboratories, Inc. - Form 483, 2018-05-21
$289 - Available for instant download
Issued On: May, 2018
Inspection Type: FDA 483
Site Name: Lusys Laboratories, Inc. [San Diego / United States of America]
Biodex Medical Systems, Inc. - EIR, 2018-05-01
$1190 - Available for instant download
Issued On: May, 2018
Inspection Type: EIR
Site Name: Biodex Medical Systems, Inc. [Shirley / United States of America]
Biodex Medical Systems, Inc. - Form 483, 2018-05-01
$289 - Available for instant download
Issued On: May, 2018
Inspection Type: FDA 483
Site Name: Biodex Medical Systems, Inc. [Shirley / United States of America]
Nortech Systems, Inc. - Form 483, 2018-04-02
$289 - Available for instant download
Issued On: April, 2018
Inspection Type: FDA 483
Site Name: Nortech Systems, Inc. [Milaca / United States of America]
Nortech Systems, Inc. - EIR, 2018-04-02
$1190 - Available for instant download
Issued On: April, 2018
Inspection Type: EIR
Site Name: Nortech Systems, Inc. [Milaca / United States of America]
ImClone Systems LLC - Form 483R, 2018-03-27
$289 - Available for instant download
Issued On: March, 2018
Inspection Type: FDA 483 Response
Site Name: ImClone Systems LLC [Jersey / United States of America]
ImClone Systems LLC - Form 483, 2018-03-09
$289 - Available for instant download
Issued On: March, 2018
Inspection Type: FDA 483
Site Name: ImClone Systems LLC [Jersey / United States of America]
Euclid Systems Corporation - Form 483, 2018-03-07
$289 - Available for instant download
Issued On: March, 2018
Inspection Type: FDA 483
Site Name: Euclid Systems Corporation [Sterling / United States of America]
American Medical Systems Innovations - EIR, 2018-02-27
$1190 - Available for instant download
Issued On: February, 2018
Inspection Type: EIR
Site Name: American Medical Systems Innovations [San Jose / United States of America]
American Medical Systems Innovations - Form 483, 2018-02-27
$289 - Available for instant download
Issued On: February, 2018
Inspection Type: FDA 483
Site Name: American Medical Systems Innovations [San Jose / United States of America]
Fresh Express/B.C. Systems, Inc. - EIR, 2018-02-14
$1190 - Available for instant download
Issued On: February, 2018
Inspection Type: EIR
Site Name: Fresh Express/B.C. Systems, Inc. [Yuma / United States of America]
Physician Software Systems LLC - Form 483, 2018-02-07
$289 - Available for instant download
Issued On: February, 2018
Inspection Type: FDA 483
Site Name: Physician Software Systems LLC [Lisle / United States of America]
Transonic Systems Inc - Form 483, 2018-02-01
$289 - Available for instant download
Issued On: February, 2018
Inspection Type: FDA 483
Site Name: Transonic Systems Inc [Ithaca / United States of America]
Mello-D Jerseys - Form 483, 2018-01-26
$289 - Available for instant download
Issued On: January, 2018
Inspection Type: FDA 483
Site Name: Mello-D Jerseys [Hanford / United States of America]
Krzysztof Wilk, M.D., Ph.D. - Form 483, 2018-01-26
$289 - Available for instant download
Issued On: January, 2018
Inspection Type: FDA 483
PTI Royston, LLC - EIR, 2018-01-11
$1190 - Available for instant download
Issued On: January, 2018
Inspection Type: EIR
Site Name: PTI Royston, LLC [Royston Georgia / United States of America]
PTI Royston, LLC - Form 483, 2018-01-11
$289 - Available for instant download
Issued On: January, 2018
Inspection Type: FDA 483
Site Name: PTI Royston, LLC [Royston Georgia / United States of America]
Physio-Control, Inc. - Form 483, 2017-12-15
$289 - Available for instant download
Issued On: December, 2017
Inspection Type: FDA 483
Site Name: Physio-Control, Inc. [Redmond / United States of America]
King Systems Corp. dba Ambu, Inc. - Form 483, 2017-11-28
$289 - Available for instant download
Issued On: November, 2017
Inspection Type: FDA 483
Site Name: King Systems Corp. dba Ambu, Inc. [Noblesville / United States of America]
M Dialysis AB - Form 483, 2017-11-09
$289 - Available for instant download
Issued On: November, 2017
Inspection Type: FDA 483
Site Name: M Dialysis AB [Stockholm / Sweden]
Fujifilm Medical Systems USA, Inc - EIR, 2017-11-08
$1190 - Available for instant download
Issued On: November, 2017
Inspection Type: EIR
Site Name: Fujifilm Medical Systems USA, Inc [Morrisville / United States of America]
Keystone Pharmacy - Form 483, 2017-11-03
$289 - Available for instant download
Issued On: November, 2017
Inspection Type: FDA 483
Site Name: Keystone Pharmacy [Grand Rapids / United States of America]
Biocare Systems, Inc. - Form 483, 2017-10-31
$289 - Available for instant download
Issued On: October, 2017
Inspection Type: FDA 483
Site Name: Biocare Systems, Inc. [Parker / United States of America]
Repro-Med Systems, Inc. - Form 483, 2017-10-19
$289 - Available for instant download
Issued On: October, 2017
Inspection Type: FDA 483
Site Name: Repro-Med Systems, Inc. [Chester / United States of America]
Repro-Med Systems, Inc. - EIR, 2017-10-19
$1190 - Available for instant download
Issued On: October, 2017
Inspection Type: EIR
Site Name: Repro-Med Systems, Inc. [Chester / United States of America]
Repro-Med Systems, Inc. - Form 483R, 2017-10-19
$289 - Available for instant download
Issued On: October, 2017
Inspection Type: FDA 483 Response
Site Name: Repro-Med Systems, Inc. [Chester / United States of America]
Technocom Systems Sdn Bhd - EIR, 2017-10-13
$1190 - Available for instant download
Issued On: October, 2017
Inspection Type: EIR
Site Name: Technocom Systems Sdn Bhd [Johor Bahru / Malaysia]
On Site Gas Systems Inc. - Form 483, 2017-10-03
$289 - Available for instant download
Issued On: October, 2017
Inspection Type: FDA 483
Site Name: On Site Gas Systems Inc. [Newington / United States of America]
Terumo Cardiovascular Systems Corp - Form 483, 2017-09-25
$289 - Available for instant download
Issued On: September, 2017
Inspection Type: FDA 483
Site Name: Terumo Cardiovascular Systems Corp [Ashland / United States of America]
Terumo Cardiovascular Systems Corp - EIR, 2017-09-25
$1190 - Available for instant download
Issued On: September, 2017
Inspection Type: EIR
Site Name: Terumo Cardiovascular Systems Corp [Ashland / United States of America]
ImClone Systems LLC - EIR, 2017-09-21
$1190 - Available for instant download
Issued On: September, 2017
Inspection Type: EIR
Site Name: ImClone Systems LLC [Jersey / United States of America]
Brit Systems - Form 483, 2017-09-01
$289 - Available for instant download
Issued On: September, 2017
Inspection Type: FDA 483
Henrys Farm Inc. - Form 483, 2017-08-31
$289 - Available for instant download
Issued On: August, 2017
Inspection Type: FDA 483
Site Name: Henrys Farm Inc. [Woodford / United States of America]
Genesis Biosystems, Inc - Form 483, 2017-08-31
$289 - Available for instant download
Issued On: August, 2017
Inspection Type: FDA 483
Site Name: Genesis Biosystems, Inc [Lewisville / United States of America]
Philips Medical Systems (Cleveland) Inc - Form 483, 2017-08-18
$289 - Available for instant download
Issued On: August, 2017
Inspection Type: FDA 483
Site Name: Philips Medical Systems (Cleveland) Inc [Cleveland / United States of America]
SynCardia Systems LLC - Form 483R, 2017-09-11
$289 - Available for instant download
Issued On: August, 2017
Inspection Type: FDA 483 Response
Site Name: SynCardia Systems LLC [Tucson / United States of America]
Philips Medical Systems (Cleveland) Inc - EIR, 2017-08-18
$1190 - Available for instant download
Issued On: August, 2017
Inspection Type: EIR
Site Name: Philips Medical Systems (Cleveland) Inc [Cleveland / United States of America]
SynCardia Systems LLC - Form 483, 2017-08-18
$289 - Available for instant download
Issued On: August, 2017
Inspection Type: FDA 483
Site Name: SynCardia Systems LLC [Tucson / United States of America]
Katalyst Surgical, LLC - Form 483, 2017-08-07
$289 - Available for instant download
Issued On: August, 2017
Inspection Type: FDA 483
Site Name: Katalyst Surgical, LLC [Chesterfield / United States of America]
Jeffreys Drug Store - Form 483, 2017-08-04
$289 - Available for instant download
Issued On: August, 2017
Inspection Type: FDA 483
Site Name: Jeffreys Drug Store [Canonsburg / United States of America]
Mercy Health System IRB - Form 483, 2017-08-03
$289 - Available for instant download
Issued On: August, 2017
Inspection Type: FDA 483
Site Name: Mercy Health System IRB [Janesville / United States of America]
Becton Dickinson Medical Systems - EIR, 2017-08-02
$1190 - Available for instant download
Issued On: August, 2017
Inspection Type: EIR
Site Name: Becton Dickinson Medical Systems [Canaan / United States of America]
Motion Analysis Corporation - Form 483, 2017-07-21
$289 - Available for instant download
Issued On: July, 2017
Inspection Type: FDA 483
Site Name: Motion Analysis Corporation [Santa Rosa / United States of America]
Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy - Form 483, 2017-07-20
$289 - Available for instant download
Issued On: July, 2017
Inspection Type: FDA 483
Site Name: Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy [Fort Myers / United States of America]
Varian Medical Systems Haan GmbH - Form 483, 2017-07-20
$289 - Available for instant download
Issued On: July, 2017
Inspection Type: FDA 483
Site Name: Varian Medical Systems Haan GmbH [Haan / Germany]
LTS Lohmann Therapy Systems Corp. - Form 483, 2017-07-13
$289 - Available for instant download
Issued On: July, 2017
Inspection Type: FDA 483
Site Name: LTS Lohmann Therapy Systems Corp. [Jersey / United States of America]
Adroit Medical Systems Inc - Form 483, 2017-07-12
$289 - Available for instant download
Issued On: July, 2017
Inspection Type: FDA 483
Site Name: Adroit Medical Systems Inc [Loudon / United States of America]
Integrity Systems LLC - Form 483, 2017-06-06
$289 - Available for instant download
Issued On: June, 2017
Inspection Type: FDA 483
Site Name: Integrity Systems LLC [Olive Branch / United States of America]
Easyscan BV - Form 483, 2017-06-01
$289 - Available for instant download
Issued On: June, 2017
Inspection Type: FDA 483
Site Name: Easyscan BV ['s-Gravenhage / Netherlands]
Crystal Geyser Water Company Inc. - EIR, 2017-05-26
$1190 - Available for instant download
Issued On: May, 2017
Inspection Type: EIR
Site Name: Crystal Geyser Water Company Inc. [Bakersfield / United States of America]
Crystal Geyser Water Company Inc. - Form 483, 2017-05-26
$289 - Available for instant download
Issued On: May, 2017
Inspection Type: FDA 483
Site Name: Crystal Geyser Water Company Inc. [Bakersfield / United States of America]
Tyson Fresh Meats, Inc. - EIR, 2017-05-10
$1190 - Available for instant download
Issued On: May, 2017
Inspection Type: EIR
Site Name: Tyson Fresh Meats, Inc. [Amarillo / United States of America]
Advanced Crystal Therapies - Form 483, 2017-04-25
$289 - Available for instant download
Issued On: April, 2017
Inspection Type: FDA 483
Site Name: Advanced Crystal Therapies [Dayton / United States of America]
Sysco Food Services of Baltimore, LLC - Form 483, 2017-04-13
$289 - Available for instant download
Issued On: April, 2017
Inspection Type: FDA 483
Site Name: Sysco Food Services of Baltimore, LLC [Jessup / United States of America]
Validation Systems, Inc. - Form 483, 2017-04-13
$289 - Available for instant download
Issued On: April, 2017
Inspection Type: FDA 483
Site Name: Validation Systems, Inc. [Palo Alto / United States of America]
Validation Systems, Inc. - Form 483R, 2017-04-27
$289 - Available for instant download
Issued On: April, 2017
Inspection Type: FDA 483 Response
Site Name: Validation Systems, Inc. [Palo Alto / United States of America]
Direx Systems Corp. - Form 483, 2017-04-12
$289 - Available for instant download
Issued On: April, 2017
Inspection Type: FDA 483
Site Name: Direx Systems Corp. [Canton / United States of America]
3D SYSTEMS - LAYERWISE - Form 483, 2017-04-06
$289 - Available for instant download
Issued On: April, 2017
Inspection Type: FDA 483
Site Name: 3D SYSTEMS - LAYERWISE [Leuven / Belgium]
Mevion Medical Systems, Inc. - Form 483, 2017-03-30
$289 - Available for instant download
Issued On: March, 2017
Inspection Type: FDA 483
Site Name: Mevion Medical Systems, Inc. [Littleton / United States of America]
ELITech Clinical Systems SAS - EIR, 2017-03-30
$1190 - Available for instant download
Issued On: March, 2017
Inspection Type: EIR
Site Name: ELITech Clinical Systems SAS [Sees / France]
OPTI Medical Systems, Inc - Form 483, 2017-03-29
$289 - Available for instant download
Issued On: March, 2017
Inspection Type: FDA 483
Site Name: OPTI Medical Systems, Inc [Roswell / United States of America]
LTS Therapy Systems, LLC - Form 483, 2017-03-29
$289 - Available for instant download
Issued On: March, 2017
Inspection Type: FDA 483
Site Name: LTS Therapy Systems, LLC [West St. Paul / United States of America]
TIdewater Physicians for Women dba Franklin Morgan Jr., M.D. - Form 483, 2017-03-27
$289 - Available for instant download
Issued On: March, 2017
Inspection Type: FDA 483
Site Name: TIdewater Physicians for Women dba Franklin Morgan Jr., M.D. [Norfolk / United States of America]
Medical Alignment Systems - Form 483, 2017-03-24
$289 - Available for instant download
Issued On: March, 2017
Inspection Type: FDA 483
Site Name: Medical Alignment Systems [Centerville / United States of America]
Tyson Bioresearch Inc. - Form 483, 2017-03-23
$289 - Available for instant download
Issued On: March, 2017
Inspection Type: FDA 483
Site Name: Tyson Bioresearch Inc. [- / Taiwan]
Merit Medical Systems, Inc. - EIR, 2017-03-15
$1190 - Available for instant download
Issued On: March, 2017
Inspection Type: EIR
Site Name: Merit Medical Systems, Inc. [South Jordan / United States of America]
Jiangmen Nowadays Daily Goods Co., Ltd. - Form 483, 2017-03-09
$289 - Available for instant download
Issued On: March, 2017
Inspection Type: FDA 483
Site Name: Jiangmen Nowadays Daily Goods Co., Ltd. [Jiangmen / China]
Roche Molecular Systems, Inc. - EIR, 2017-02-27
$1190 - Available for instant download
Issued On: February, 2017
Inspection Type: EIR
Site Name: Roche Molecular Systems, Inc. [Pleasanton / United States of America]
Meridian Medical Systems LLC - Form 483, 2017-02-24
$289 - Available for instant download
Issued On: February, 2017
Inspection Type: FDA 483
Site Name: Meridian Medical Systems LLC [Aurora / United States of America]
Organ Recovery Systems, Inc. - Form 483, 2017-02-10
$289 - Available for instant download
Issued On: February, 2017
Inspection Type: FDA 483
Site Name: Organ Recovery Systems, Inc. [Itasca / United States of America]
Organ Recovery Systems, Inc. - EIR, 2017-02-10
$1190 - Available for instant download
Issued On: February, 2017
Inspection Type: EIR
Site Name: Organ Recovery Systems, Inc. [Itasca / United States of America]
International Medication Systems, Ltd. - Form 483, 2017-02-09
$289 - Available for instant download
Issued On: February, 2017
Inspection Type: FDA 483
Site Name: International Medication Systems, Ltd. [South El Monte / United States of America]
Hitachi Medical Systems America Inc - Form 483, 2017-02-06
$289 - Available for instant download
Issued On: February, 2017
Inspection Type: FDA 483
Site Name: Hitachi Medical Systems America Inc [Twinsburg / United States of America]
Shandong Analysis and Test Center - Form 483, 2017-01-18
$289 - Available for instant download
Issued On: January, 2017
Inspection Type: FDA 483
Site Name: Shandong Analysis and Test Center [Jinan / China]
Repro-Med Systems, Inc. - Form 483, 2016-12-16
$289 - Available for instant download
Issued On: December, 2016
Inspection Type: FDA 483
Site Name: Repro-Med Systems, Inc. [Chester / United States of America]
Lusys Laboratories, Inc. - Form 483, 2016-12-08
$289 - Available for instant download
Issued On: December, 2016
Inspection Type: FDA 483
Site Name: Lusys Laboratories, Inc. [San Diego / United States of America]
International Medication Systems, Ltd. - Form 483, 2016-12-07
$289 - Available for instant download
Issued On: December, 2016
Inspection Type: FDA 483
Site Name: International Medication Systems, Ltd. [South El Monte / United States of America]
CEI Physicians PSC Inc. - Form 483, 2016-12-06
$289 - Available for instant download
Issued On: December, 2016
Inspection Type: FDA 483
Site Name: CEI Physicians PSC Inc. [Blue Ash / United States of America]
Rhinosystems Inc - Form 483, 2016-12-02
$289 - Available for instant download
Issued On: December, 2016
Inspection Type: FDA 483
Site Name: Rhinosystems Inc [Brooklyn Heights / United States of America]
Biomedical Systems Corp - Form 483, 2016-11-17
$289 - Available for instant download
Issued On: November, 2016
Inspection Type: FDA 483
Site Name: Biomedical Systems Corp [Maryland Heights / United States of America]
Biomedical Systems Corp - EIR, 2016-11-17
$1190 - Available for instant download
Issued On: November, 2016
Inspection Type: EIR
Site Name: Biomedical Systems Corp [Maryland Heights / United States of America]
Delcath Systems Inc. - EIR, 2016-11-09
$1190 - Available for instant download
Issued On: November, 2016
Inspection Type: EIR
Site Name: Delcath Systems Inc. [Queensbury / United States of America]
SRS Medical Systems Inc. - Form 483, 2016-11-04
$289 - Available for instant download
Issued On: November, 2016
Inspection Type: FDA 483
Site Name: SRS Medical Systems Inc. [North Billerica / United States of America]
Maquet Medical Systems USA - Form 483, 2016-09-29
$289 - Available for instant download
Issued On: September, 2016
Inspection Type: FDA 483
Site Name: Maquet Medical Systems USA [Wayne / United States of America]
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. - Form 483, 2016-09-23
$289 - Available for instant download
Issued On: September, 2016
Inspection Type: FDA 483
Site Name: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. [Dover / United States of America]
Krzysztof W. Selmaj, M.D., Ph.D. - Form 483, 2016-09-23
$289 - Available for instant download
Issued On: September, 2016
Inspection Type: FDA 483
Crosbys Drugs Inc - Form 483, 2016-09-16
$289 - Available for instant download
Issued On: September, 2016
Inspection Type: FDA 483
Site Name: Crosbys Drugs Inc [Columbus / United States of America]
Terumo Cardiovascular Systems Corporation - Form 483, 2016-09-15
$289 - Available for instant download
Issued On: September, 2016
Inspection Type: FDA 483
Site Name: Terumo Cardiovascular Systems Corporation [Elkton / United States of America]
Cardiovascular Systems Inc - EIR, 2016-09-01
$1190 - Available for instant download
Issued On: September, 2016
Inspection Type: EIR
Site Name: Cardiovascular Systems Inc [Saint Paul / United States of America]
RF Surgical System Inc Technical Center - Form 483R, 2016-09-12
$289 - Available for instant download
Issued On: August, 2016
Inspection Type: FDA 483 Response
Site Name: RF Surgical System Inc Technical Center [Carlsbad / United States of America]
RF Surgical System Inc Technical Center - Form 483, 2016-08-18
$289 - Available for instant download
Issued On: August, 2016
Inspection Type: FDA 483
Site Name: RF Surgical System Inc Technical Center [Carlsbad / United States of America]
Florida Crystals Food Corporation - Form 483, 2016-08-11
$289 - Available for instant download
Issued On: August, 2016
Inspection Type: FDA 483
Site Name: Florida Crystals Food Corporation [South Bay / United States of America]
Mindways Software, Inc. - Form 483, 2016-08-05
$289 - Available for instant download
Issued On: August, 2016
Inspection Type: FDA 483
Site Name: Mindways Software, Inc. [Austin / United States of America]
R & D Systems, Inc. - Form 483, 2016-08-04
$289 - Available for instant download
Issued On: August, 2016
Inspection Type: FDA 483
Site Name: R & D Systems, Inc. [Minneapolis / United States of America]
Coating Systems Laboratories, Inc - EIR, 2016-08-02
$1190 - Available for instant download
Issued On: August, 2016
Inspection Type: EIR
Site Name: Coating Systems Laboratories, Inc [Chandler / United States of America]
Coating Systems Laboratories, Inc - Form 483, 2016-08-02
$289 - Available for instant download
Issued On: August, 2016
Inspection Type: FDA 483
Site Name: Coating Systems Laboratories, Inc [Chandler / United States of America]
Cardiovascular Systems, Inc. - EIR, 2016-07-12
$1190 - Available for instant download
Issued On: July, 2016
Inspection Type: EIR
Site Name: Cardiovascular Systems, Inc. [Houston / United States of America]
Targeted Medical Pharma, Inc. dba Physician Therapeutics - Form 483, 2016-07-01
$289 - Available for instant download
Issued On: July, 2016
Inspection Type: FDA 483
Site Name: Targeted Medical Pharma, Inc. dba Physician Therapeutics [Los Angeles / United States of America]
Targeted Medical Pharma, Inc. dba Physician Therapeutics - Form 483R, 2016-07-18
$289 - Available for instant download
Issued On: July, 2016
Inspection Type: FDA 483 Response
Site Name: Targeted Medical Pharma, Inc. dba Physician Therapeutics [Los Angeles / United States of America]