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CERTIFIED SAFETY MANUFACTURING, INC. - Form 483, 2019-10-15
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: CERTIFIED SAFETY MANUFACTURING, INC. [Kansas City / United States of America]
Sawai Pharmaceutical Co., Ltd. - Form 483, 2019-10-15
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Sawai Pharmaceutical Co., Ltd. [Sunayama / Japan]
Biedermann Motech, Inc. - Form 483, 2019-10-15
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Biedermann Motech, Inc. [Miami / United States of America]
CIS Bio International - Form 483, 2019-10-15
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Taejoon Pharmaceutical Co., Ltd. - Form 483, 2019-10-15
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Taejoon Pharmaceutical Co., Ltd. [Cheoin-Gu / Korea (Republic of)]
INDOCO REMEDIES LIMITED - Form 483, 2019-10-15
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: INDOCO REMEDIES LIMITED [Salcete / India]
Patheon Puerto Rico, Inc. - Form 483, 2019-10-15
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Patheon Puerto Rico, Inc. [Coto Norte / Puerto Rico]
California IVF Fertility Center - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: California IVF Fertility Center [Sacramento / United States of America]
Flowonix Medical Inc - EIR, 2019-10-29
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: Flowonix Medical Inc [Mansfield / United States of America]
Douglas Manufacturing Limited - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Douglas Manufacturing Limited [Auckland / New Zealand]
Air-Tite Products Co Inc - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Air-Tite Products Co Inc [Virginia Beach / United States of America]
Hollywood Health Products, Inc. - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Hollywood Health Products, Inc. [Sunrise / United States of America]
Shady Grove Fertility - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Shady Grove Fertility [Arlington / United States of America]
Botanical Resources Australia-Manufacturing Services Pty Ltd - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Botanical Resources Australia-Manufacturing Services Pty Ltd [Ulverstone / Australia]
Catalent Nottingham Limited - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Catalent Nottingham Limited [Nottingham / United Kingdom of Great Britain and Northern Ireland]
Amphastar Nanjing Pharmaceuticals Inc. - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Amphastar Nanjing Pharmaceuticals Inc. [Nanjing / China]
FUJIFILM Diosynth Biotechnologies Denmark ApS - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: FUJIFILM Diosynth Biotechnologies Denmark ApS [Hillerød / Denmark]
Eurofins CDMO Alphora Inc - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Hisamitsu Pharmaceutical Co., Inc. - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Hisamitsu Pharmaceutical Co., Inc. [Kiyoharakogyodanchi / Japan]
Transfer Technology, Inc. - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Transfer Technology, Inc. [Huntington Beach / United States of America]
Terumo Cardiovascular Systems Corporation - EIR, 2019-12-11
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: Terumo Cardiovascular Systems Corporation [Ann Arbor / United States of America]
Milbar Laboratories, Inc. - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Milbar Laboratories, Inc. [East Haven / United States of America]
Flowonix Medical Inc - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Flowonix Medical Inc [Mansfield / United States of America]
Tosoh Bioscience Inc - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Tosoh Bioscience Inc [Grove City / United States of America]
Trinity Hospital IRB # 1 - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Trinity Hospital IRB # 1 [Minot / United States of America]
Frederick J. Snoy, M.D. - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Frederick J. Snoy, M.D. [Albuquerque / United States of America]
ITG Electronics (Malaysia) Sdn Bhd - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: ITG Electronics (Malaysia) Sdn Bhd [Johor Bahru / Malaysia]
International Sterilization Laboratory, LLC - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: International Sterilization Laboratory, LLC [Groveland / United States of America]
APN Health LLC - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: APN Health LLC [Waukesha / United States of America]
Oxus, Inc. - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Oxus, Inc. [Auburn Hills / United States of America]
Atlanta Hyperbaric Center LLC - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Atlanta Hyperbaric Center LLC [Powder Springs / United States of America]
Oxus, Inc. - EIR, 2019-10-20
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: Oxus, Inc. [Auburn Hills / United States of America]
Global Medical Technology SL - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Global Medical Technology SL [San Sebastián De Los Reyes / Spain]
Caliber Imaging and Diagnostics, Inc. - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Caliber Imaging and Diagnostics, Inc. [Rochester / United States of America]
LEXAMED - EIR, 2019-10-10
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: LEXAMED [Toledo / United States of America]
LEXAMED - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: LEXAMED [Toledo / United States of America]
Wello, Inc. - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Monitor Instruments, Inc. - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Monitor Instruments, Inc. [Hillsborough / United States of America]
PBM Nutritionals, LLC - EIR, 2019-10-10
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: PBM Nutritionals, LLC [Covington / United States of America]
Techni Med, Inc. dba The Compounder - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Techni Med, Inc. dba The Compounder [Aurora / United States of America]
Orthocare Innovations, LLC - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Orthocare Innovations, LLC [Edmonds / United States of America]
Richard Bernstein, MD, PhD - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Richard Bernstein, MD, PhD [Chicago / United States of America]
APN Health LLC - Form 483R, 2019-11-01
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483 Response
Site Name: APN Health LLC [Waukesha / United States of America]
Perryman Company - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Perryman Company [Houston / United States of America]
APN Health LLC - EIR, 2019-10-18
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: APN Health LLC [Waukesha / United States of America]
Medegen Medical Products, LLC - Form 483, 2019-10-10
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Medegen Medical Products, LLC [Arlington / United States of America]
KarePak LLC - Form 483, 2019-10-09
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
SpineNet LLC. - Form 483, 2019-10-09
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: SpineNet LLC. [Winter Park / United States of America]
Lyons Magnus East, LLC - EIR, 2019-10-08
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: Lyons Magnus East, LLC [Walton / United States of America]
Honest Globe, Inc. - Form 483, 2019-10-08
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Honest Globe, Inc. [Santa Ana / United States of America]
David Fuentes, M.D. - Form 483, 2019-10-08
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: David Fuentes, M.D. [Boerne / United States of America]
Astellas Pharma Inc. - Form 483, 2019-10-07
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Astellas Pharma Inc. [Kojimmachi / Japan]
Tusker Medical, Inc. - EIR, 2019-10-08
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: Tusker Medical, Inc. [Menlo Park / United States of America]
Netech Corp. - Form 483, 2019-10-08
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Netech Corp. [Farmingdale / United States of America]
Tusker Medical, Inc. - Form 483, 2019-10-08
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Tusker Medical, Inc. [Menlo Park / United States of America]
Surgical Principals Inc - Form 483, 2019-10-08
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Surgical Principals Inc [Tacoma / United States of America]
Banner Pharmacy Services, LLC - Form 483, 2019-10-08
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Banner Pharmacy Services, LLC [Chandler / United States of America]
Marzetti Frozen Pasta, Inc. - EIR, 2019-10-08
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: Marzetti Frozen Pasta, Inc. [Clive / United States of America]
Givaudan Flavor Corp. - EIR, 2019-10-08
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: Givaudan Flavor Corp. [East Hanover / United States of America]
Natren Inc. - Form 483, 2019-10-08
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Natren Inc. [Thousand Oaks / United States of America]
ATC Technologies, Inc. - Form 483, 2019-10-07
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: ATC Technologies, Inc. [Wilmington / United States of America]
We are Blood - Form 483, 2019-10-07
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: We are Blood [Round Rock / United States of America]
American Contract Systems, Inc. - Form 483, 2019-10-04
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: American Contract Systems, Inc. [Houston / United States of America]
Mehrdad Kevin Ariani, MD - Form 483, 2019-10-04
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Mehrdad Kevin Ariani, MD [Northridge / United States of America]
ISP Chemicals LLC - EIR, 2019-10-04
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: ISP Chemicals LLC [Calvert City / United States of America]
Astellas Pharma US Inc. - EIR, 2019-10-04
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: Astellas Pharma US Inc. [Northbrook / United States of America]
Simplot Frozen Vegetables LLC - Form 483, 2019-10-04
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Simplot Frozen Vegetables LLC [Pasco / United States of America]
SEAGEN INC. - EIR, 2019-10-04
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Astellas Pharma US Inc. - Form 483R, 2019-10-24
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483 Response
Site Name: Astellas Pharma US Inc. [Northbrook / United States of America]
Alan E. Kimura, M.D. - Form 483, 2019-10-04
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Alan E. Kimura, M.D. [Golden / United States of America]
Simplot Frozen Vegetables LLC - Form 483R, 2019-10-23
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483 Response
Site Name: Simplot Frozen Vegetables LLC [Pasco / United States of America]
Kyowa Kirin Co., Ltd. - Form 483, 2019-10-04
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Simplot Frozen Vegetables LLC - EIR, 2019-10-04
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: Simplot Frozen Vegetables LLC [Pasco / United States of America]
Emergent Biodefense Operations Lansing LLC - Form 483, 2019-10-04
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Emergent Biodefense Operations Lansing LLC [Lansing / United States of America]
MicroVision, Inc. - Form 483, 2019-10-03
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: MicroVision, Inc. [Seabrook / United States of America]
BioTel Research, LLC - EIR, 2019-10-03
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: BioTel Research, LLC [Rochester / United States of America]
Diacor, Inc - Form 483, 2019-10-03
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Diacor, Inc [West Valley City / United States of America]
MCALISTER DRUG CORPORATION - Form 483, 2019-10-03
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: MCALISTER DRUG CORPORATION [Yukon / United States of America]
Supriya Lifescience Limited - Form 483, 2019-10-03
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Supriya Lifescience Limited [Khed / India]
Roger A. Dailey, M.D. - Form 483, 2019-10-02
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Roger A. Dailey, M.D. [Portland / United States of America]
Future Pak Ltd. - Form 483, 2019-10-02
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Future Pak Ltd. [Wixom / United States of America]
Armand Products Company - EIR, 2019-10-01
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: Armand Products Company [Muscle Shoals / United States of America]
Deerfield Imaging, Inc. - Form 483, 2019-10-01
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Deerfield Imaging, Inc. [Hopkins / United States of America]
GREFI - Form 483, 2019-10-08
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: GREFI [Coto Laurel / Puerto Rico]
Liquid Crystal Resources Hallcrest LLC - Form 483, 2019-10-01
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Liquid Crystal Resources Hallcrest LLC [Glenview / United States of America]
Olam Chile Peppers LLC - EIR, 2019-10-01
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: Olam Chile Peppers LLC [Deming / United States of America]
Olam Chile Peppers LLC - Form 483R, 2019-10-14
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483 Response
Site Name: Olam Chile Peppers LLC [Deming / United States of America]
Bajaj Medical, LLC - Form 483, 2019-10-01
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Bajaj Medical, LLC [Chicago / United States of America]
Skyline Medical, Inc. - Form 483, 2019-10-01
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Skyline Medical, Inc. [Saint Paul / United States of America]
Armand Products Company - Form 483, 2019-10-01
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Armand Products Company [Muscle Shoals / United States of America]
Olam Chile Peppers LLC - Form 483, 2019-10-01
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Olam Chile Peppers LLC [Deming / United States of America]
SBH Medical, LTD - Form 483, 2019-09-30
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: SBH Medical, LTD [Columbus / United States of America]
Blaine Labs Inc. - Form 483, 2019-09-30
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Blaine Labs Inc. [Santa Fe Springs / United States of America]
Choice Spine LLC - Form 483, 2019-09-30
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Choice Spine LLC [Knoxville / United States of America]
Medtronic Navigation, Inc. - Form 483, 2019-09-30
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Medtronic Navigation, Inc. [Lafayette / United States of America]
Pink, Inc. dba Hearten - Form 483, 2019-09-30
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Pink, Inc. dba Hearten [Henrico / United States of America]
Dukal Corporation - EIR, 2019-10-11
$1190 - Available for instant download
Issued On: September, 2019
Inspection Type: EIR
Site Name: Dukal Corporation [Ronkonkoma / United States of America]
Nature's Natural Products, INC. DBA Nature's Skin and Body Food - Form 483, 2019-09-27
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Latina Pharma S.P.A. - EIR, 2019-09-27
$1190 - Available for instant download
Issued On: September, 2019
Inspection Type: EIR
Site Name: Latina Pharma S.P.A. [Sermoneta / Italy]
Fisiopharma SRL - Form 483, 2019-09-27
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Fisiopharma SRL [Palomonte / Italy]