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BioAnalysis, LLC - Form 483, 2024-01-26
$289 - Available for instant download
Issued On: January, 2024
Inspection Type: FDA 483
Site Name: BioAnalysis, LLC [Philadelphia / United States of America]
Cbr Systems Inc - Form 483, 2024-01-17
$289 - Available for instant download
Issued On: January, 2024
Inspection Type: FDA 483
Site Name: Cbr Systems Inc [Tucson / United States of America]
Community Healthcare System - Form 483, 2023-12-15
$289 - Available for instant download
Issued On: December, 2023
Inspection Type: FDA 483
Site Name: Community Hospital [Munster / United States of America]
Roche Molecular Systems, Inc. - Form 483, 2023-12-08
$289 - Available for instant download
Issued On: December, 2023
Inspection Type: FDA 483
Site Name: Roche Molecular Systems, Inc. [S Branchburg / United States of America]
University System of New Hampshire - Form 483, 2023-12-05
$289 - Available for instant download
Issued On: December, 2023
Inspection Type: FDA 483
Site Name: University System of New Hampshire [Hampshire / United States of America]
VA Connecticut Health Care System IRB - Form 483, 2023-11-21
$289 - Available for instant download
Issued On: November, 2023
Inspection Type: FDA 483
Site Name: VA Connecticut Health Care System IRB [West Haven / United States of America]
SRS Medical Systems Inc. - Form 483, 2023-10-11
$289 - Available for instant download
Issued On: October, 2023
Inspection Type: FDA 483
Site Name: SRS Medical Systems Inc. [North Billerica / United States of America]
Computer Programs & Systems Inc - Form 483, 2023-09-13
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Computer Programs & Systems Inc [Mobile / United States of America]
Life Recovery Systems HD, LLC - Form 483, 2023-09-11
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Life Recovery Systems HD, LLC [Kinnelon / United States of America]
Aveva Drug Delivery Systems Inc. - Form 483, 2023-09-01
$289 - Available for instant download
Issued On: September, 2023
Inspection Type: FDA 483
Site Name: Aveva Drug Delivery Systems Inc. [Florida / United States of America]
Lifeaire Systems - Form 483, 2023-08-29
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Lifeaire Systems [Allentown / 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]
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]
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]
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 [Jersey / United States of America]
KEYSTONE INDUSTIRES - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: KEYSTONE INDUSTIRES [Swedesboro / United States of America]
Kaysersberg Pharmaceuticals - Form 483, 2023-07-07
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Blood Bank Computer Systems, Inc. - Form 483, 2023-06-30
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Blood Bank Computer Systems, Inc. [Bonney Lake / United States of America]
KEN Hygiene Systems A/S - Form 483, 2023-06-29
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: KEN Hygiene Systems A/S [Broby / Denmark]
Theos Medical Systems, Inc. - Form 483, 2023-06-16
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Theos Medical Systems, Inc. [Santa Clara / United States of America]
Delcath Systems Inc. - Form 483, 2023-06-09
$289 - Available for instant download
Issued On: June, 2023
Inspection Type: FDA 483
Site Name: Delcath Systems Inc. [Queensbury / United States of America]
VCU Health System Reproductive Medicine and IVF - Form 483, 2023-05-12
$289 - Available for instant download
Issued On: May, 2023
Inspection Type: FDA 483
Site Name: VCU Health System Reproductive Medicine and IVF [Richmond / United States of America]
Nortech Systems, Inc. - Form 483, 2023-04-14
$289 - Available for instant download
Issued On: April, 2023
Inspection Type: FDA 483
Site Name: Nortech Systems, Inc. [Milaca / United States of America]
Odyssey Medical Technologies, LLC. - Form 483, 2023-04-03
$289 - Available for instant download
Issued On: April, 2023
Inspection Type: FDA 483
Site Name: Odyssey Medical Technologies, LLC. [Bartlett / United States of America]
Lystn, LLC DBA Answers Pet Food - Form 483, 2023-03-30
$289 - Available for instant download
Issued On: March, 2023
Inspection Type: FDA 483
Site Name: Lystn, LLC DBA Answers Pet Food [Elizabethville / United States of America]
Mission Systems Davenport Inc. - Form 483, 2023-03-30
$289 - Available for instant download
Issued On: March, 2023
Inspection Type: FDA 483
Site Name: Mission Systems Davenport Inc. [Davenport / United States of America]
Summa Health System - Form 483, 2023-03-21
$289 - Available for instant download
Issued On: March, 2023
Inspection Type: FDA 483
Site Name: Summa Health System [Akron / United States of America]
Tricor Systems - Form 483, 2023-03-08
$289 - Available for instant download
Issued On: March, 2023
Inspection Type: FDA 483
Site Name: Tricor Systems [Elgin / United States of America]
International Medication Systems, Ltd. - Form 483, 2023-02-15
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: International Medication Systems, Ltd. [South El Monte / United States of America]
Garys Cheesecakes & Fine Desserts - Form 483, 2023-02-15
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Garys Cheesecakes & Fine Desserts [Cincinnati / United States of America]
Engineered Medical Systems, LLC - Form 483, 2023-02-10
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Engineered Medical Systems, LLC [Bartlett / United States of America]
Biodex Medical Systems, Inc. - Form 483, 2023-02-10
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Biodex Medical Systems, Inc. [Shirley / United States of America]
ELYSIUM PHARMACEUTICALS LIMITED - Form 483, 2023-01-16
$289 - Available for instant download
Issued On: January, 2023
Inspection Type: FDA 483
Genesis Biosystems, Inc - Form 483, 2023-01-09
$289 - Available for instant download
Issued On: January, 2023
Inspection Type: FDA 483
Site Name: Genesis Biosystems, Inc [Lewisville / United States of America]
Keystone Industries - Form 483, 2022-12-21
$289 - Available for instant download
Issued On: December, 2022
Inspection Type: FDA 483
Site Name: Keystone Industries [Jersey / United States of America]
Terumo Cardiovascular Systems Corporation - Form 483, 2022-12-16
$289 - Available for instant download
Issued On: December, 2022
Inspection Type: FDA 483
Site Name: Terumo Cardiovascular Systems Corporation [Elkton / United States of America]
RAYSEARCH LABORATORIES AB - Form 483, 2022-11-17
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Reliance Medical Systems LLC - Form 483, 2022-11-17
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Reliance Medical Systems LLC [Bountiful / United States of America]
Olympus Medical Systems Corp. - Form 483, 2022-11-10
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Olympus Medical Systems Corp. [Nishitama-Gun / Japan]
Fischer Analysen Instrumente Gmbh - Form 483, 2022-11-04
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Fischer Analysen Instrumente Gmbh [Leipzig / Germany]
DIZZYDOCTOR SYSTEMS LLC - EIR, 2022-10-14
$1190 - Available for instant download
Issued On: October, 2022
Inspection Type: EIR
Site Name: DIZZYDOCTOR SYSTEMS LLC [San Diego / United States of America]
DIZZYDOCTOR SYSTEMS LLC - Form 483R, 2022-10-26
$289 - Available for instant download
Issued On: October, 2022
Inspection Type: FDA 483 Response
Site Name: DIZZYDOCTOR SYSTEMS LLC [San Diego / United States of America]
Ikonisys Inc. - Form 483, 2022-10-12
$289 - Available for instant download
Issued On: October, 2022
Inspection Type: FDA 483
Site Name: Ikonisys Inc. [New Haven / United States of America]
Teledyne Flir Commercial Systems, Inc. - Form 483, 2022-10-04
$289 - Available for instant download
Issued On: October, 2022
Inspection Type: FDA 483
Site Name: Teledyne Flir Commercial Systems, Inc. [Nashua / United States of America]
Integrated Laboratory Systems LLC, An Inotiv Company - Form 483, 2022-09-30
$289 - Available for instant download
Issued On: September, 2022
Inspection Type: FDA 483
Site Name: Integrated Laboratory Systems LLC, An Inotiv Company [Morrisville / United States of America]
Body Balance System - Form 483, 2022-09-29
$289 - Available for instant download
Issued On: September, 2022
Inspection Type: FDA 483
Site Name: Body Balance System [Las Vegas / United States of America]
Olympus Medical Systems Corporation - Form 483, 2022-09-09
$289 - Available for instant download
Issued On: September, 2022
Inspection Type: FDA 483
Site Name: Olympus Medical Systems Corporation [Hachioji / Japan]
Sea-Long Medical Systems, LLC - Form 483, 2022-09-08
$289 - Available for instant download
Issued On: September, 2022
Inspection Type: FDA 483
Site Name: Sea-Long Medical Systems, LLC [Waxahachie / United States of America]
CROSSROADS EXTREMITY SYSTEMS LLC - Form 483, 2022-08-26
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: CROSSROADS EXTREMITY SYSTEMS LLC [Memphis / United States of America]
ImClone Systems LLC - Form 483, 2022-08-25
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: ImClone Systems LLC [Jersey / United States of America]
Lifeline Systems Company - Form 483, 2022-08-17
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: Lifeline Systems Company [Framingham / United States of America]
CDR SYSTEMS, INC. - Form 483, 2022-08-11
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: CDR SYSTEMS, INC. [Calgary / Canada]
Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy - Form 483, 2022-08-11
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy [Fort Myers / United States of America]
Ventec Life Systems, Inc. - Form 483, 2022-07-27
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: Ventec Life Systems, Inc. [Bothell / United States of America]
Newton Implant Systems, Inc. - Form 483, 2022-07-19
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: Newton Implant Systems, Inc. [San Diego / United States of America]
Auto-Chlor System LLC - Form 483, 2022-07-18
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: Auto-Chlor System LLC [Hapeville / United States of America]
General Physiotherapy Inc - Form 483, 2022-07-01
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: General Physiotherapy Inc [Earth City / United States of America]
SNS Biosystems - Form 483, 2022-06-24
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: SNS Biosystems [Santa Maria / United States of America]
Rowny Systems, Inc. - Form 483, 2022-06-17
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Rowny Systems, Inc. [Cabin John / United States of America]
Sanmina Sci Israel Medical Systems Ltd. - Form 483, 2022-06-16
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Sanmina Sci Israel Medical Systems Ltd. [Maalot / Israel]
Medical Measurement Systems B.V. - Form 483, 2022-06-16
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Medical Measurement Systems B.V. [Enschede / Netherlands]
Logosys Logistik GmbH - Form 483, 2022-06-15
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Logosys Logistik GmbH [Darmstadt / Germany]
Physician Software Systems LLC - Form 483, 2022-06-06
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Physician Software Systems LLC [Lisle / United States of America]
International Medication Systems, Ltd. - Form 483, 2022-05-25
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: International Medication Systems, Ltd. [South El Monte / United States of America]
NYSARC, Columbia County Chapter, Inc. - Form 483, 2022-05-13
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: NYSARC, Columbia County Chapter, Inc. [Mellenville / United States of America]
Amarillo VA Health Care System - Blood Bank - Form 483, 2022-04-19
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: Amarillo VA Health Care System - Blood Bank [Amarillo / United States of America]
American Contract Systems, Inc. - Form 483, 2022-04-08
$289 - Available for instant download
Issued On: April, 2022
Inspection Type: FDA 483
Site Name: American Contract Systems, Inc. [Temple Terrace / United States of America]
Ochsner Health System Blood Bank - Form 483, 2022-03-31
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Ochsner Health System Blood Bank [New Orleans / United States of America]
Angel Medical Systems, Inc. - Form 483, 2022-03-28
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Angel Medical Systems, Inc. [Eatontown / United States of America]
American Contract Systems - EIR, 2022-04-14
$1190 - Available for instant download
Issued On: March, 2022
Inspection Type: EIR
Site Name: American Contract Systems [Zelienople / United States of America]
Pajunk Medical Systems, L.P. - Form 483, 2022-03-18
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: Pajunk Medical Systems, L.P. [Alpharetta / United States of America]
American Contract Systems, Inc. - Form 483, 2022-03-02
$289 - Available for instant download
Issued On: March, 2022
Inspection Type: FDA 483
Site Name: American Contract Systems, Inc. [Kansas City / United States of America]
Integrated Ophthalmic Systems, Inc - Form 483, 2021-12-15
$289 - Available for instant download
Issued On: December, 2021
Inspection Type: FDA 483
Site Name: Integrated Ophthalmic Systems, Inc [Woburn / United States of America]
Stratus BioSystems, LLC - Form 483, 2021-11-10
$289 - Available for instant download
Issued On: November, 2021
Inspection Type: FDA 483
Site Name: Stratus BioSystems, LLC [Grapevine / United States of America]
Crystalmark Dental Systems Inc - Form 483, 2021-10-22
$289 - Available for instant download
Issued On: October, 2021
Inspection Type: FDA 483
Site Name: Crystalmark Dental Systems Inc [Glendale / United States of America]
Valley Biosystems - Form 483, 2021-10-08
$289 - Available for instant download
Issued On: October, 2021
Inspection Type: FDA 483
Site Name: Valley Biosystems [West Sacramento / United States of America]
Expert Chemical Analysis, Inc. - Form 483, 2021-10-07
$289 - Available for instant download
Issued On: October, 2021
Inspection Type: FDA 483
Site Name: Expert Chemical Analysis, Inc. [San Diego / United States of America]
Crosbys Drugs Inc - Form 483, 2021-09-30
$289 - Available for instant download
Issued On: September, 2021
Inspection Type: FDA 483
Site Name: Crosbys Drugs Inc [Columbus / United States of America]
Unimicro Medical Systems (Shenzhen) Co., Ltd. - Form 483, 2021-09-26
$289 - Available for instant download
Issued On: September, 2021
Inspection Type: FDA 483
Site Name: Unimicro Medical Systems (Shenzhen) Co., Ltd. [Shenzhen / China]
T2 Biosystems, Inc. - Form 483, 2021-09-24
$289 - Available for instant download
Issued On: September, 2021
Inspection Type: FDA 483
Site Name: T2 Biosystems, Inc. [Lexington / United States of America]
Lusys Laboratories, Inc. - Form 483, 2021-09-24
$289 - Available for instant download
Issued On: September, 2021
Inspection Type: FDA 483
Site Name: Lusys Laboratories, Inc. [San Diego / United States of America]
Enthermics Medical Systems, Inc. - Form 483, 2021-09-16
$289 - Available for instant download
Issued On: September, 2021
Inspection Type: FDA 483
Site Name: Enthermics Medical Systems, Inc. [Menomonee Falls / United States of America]
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. - Form 483, 2021-09-07
$289 - Available for instant download
Issued On: September, 2021
Inspection Type: FDA 483
Site Name: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. [Whitestown / United States of America]
Avox Systems Inc - Form 483, 2021-08-16
$289 - Available for instant download
Issued On: August, 2021
Inspection Type: FDA 483
Site Name: Avox Systems Inc [Lancaster / United States of America]
Aesculap Implant Systems LLC - Form 483, 2021-08-11
$289 - Available for instant download
Issued On: August, 2021
Inspection Type: FDA 483
Site Name: Aesculap Implant Systems LLC [Center Valley / United States of America]
Lee Memorial Health System - Form 483, 2021-08-12
$289 - Available for instant download
Issued On: August, 2021
Inspection Type: FDA 483
Site Name: Lee Memorial Health System [Fort Myers / United States of America]
Custom Industrial Analysis Laboratories - Form 483, 2021-08-04
$289 - Available for instant download
Issued On: August, 2021
Inspection Type: FDA 483
Site Name: Custom Industrial Analysis Laboratories [Saint Joseph / United States of America]
Custom Industrial Analysis Laboratories - EIR, 2021-08-04
$1190 - Available for instant download
Issued On: August, 2021
Inspection Type: EIR
Site Name: Custom Industrial Analysis Laboratories [Saint Joseph / United States of America]
AngioDynamics, Inc. DBA Navilyst Medical Inc. - Form 483, 2021-06-25
$289 - Available for instant download
Issued On: June, 2021
Inspection Type: FDA 483
Site Name: AngioDynamics, Inc. DBA Navilyst Medical Inc. [Glens Falls / United States of America]
AngioDynamics, Inc. DBA Navilyst Medical Inc. - Form 483, 2021-06-25
$289 - Available for instant download
Issued On: June, 2021
Inspection Type: FDA 483
Site Name: AngioDynamics, Inc. DBA Navilyst Medical Inc. [Glens Falls / United States of America]
Svelte Medical Systems - Form 483, 2021-06-14
$289 - Available for instant download
Issued On: June, 2021
Inspection Type: FDA 483
Site Name: Svelte Medical Systems [New Providence / United States of America]
Aesculap Implant Systems LLC - Form 483, 2021-06-08
$289 - Available for instant download
Issued On: June, 2021
Inspection Type: FDA 483
Site Name: Aesculap Implant Systems LLC [Breinigsville / United States of America]
Ventec Life Systems, Inc. - Form 483, 2021-05-12
$289 - Available for instant download
Issued On: May, 2021
Inspection Type: FDA 483
Site Name: Ventec Life Systems, Inc. [Bothell / United States of America]
King Systems Corp. dba Ambu, Inc. - Form 483, 2021-04-15
$289 - Available for instant download
Issued On: April, 2021
Inspection Type: FDA 483
Site Name: King Systems Corp. dba Ambu, Inc. [Noblesville / United States of America]
Sky Systems Co., Inc - Form 483, 2020-09-30
$289 - Available for instant download
Issued On: September, 2020
Inspection Type: FDA 483
Site Name: Sky Systems Co., Inc [California / United States of America]
Transtracheal Systems, Inc. - Form 483, 2020-09-17
$289 - Available for instant download
Issued On: September, 2020
Inspection Type: FDA 483
Site Name: Transtracheal Systems, Inc. [Englewood / United States of America]
ImClone Systems LLC - Form 483R, 2020-09-14
$289 - Available for instant download
Issued On: August, 2020
Inspection Type: FDA 483 Response
Site Name: ImClone Systems LLC [Jersey / United States of America]
ImClone Systems LLC - Form 483, 2020-08-21
$289 - Available for instant download
Issued On: August, 2020
Inspection Type: FDA 483
Site Name: ImClone Systems LLC [Jersey / United States of America]
Mevion Medical Systems, Inc. - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Mevion Medical Systems, Inc. [Littleton / United States of America]
All Ways Dental, LLC. - Form 483, 2020-02-26
$289 - Available for instant download
Issued On: February, 2020
Inspection Type: FDA 483
Site Name: All Ways Dental, LLC. [Apache Junction / United States of America]