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WINDER LABORATORIES, LLC - Form 483, 2020-03-13
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: WINDER LABORATORIES, LLC [Winder / United States of America]
Jessica Kaffenberger, M.D. - Form 483, 2020-03-13
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Jessica Kaffenberger, M.D. [Columbus / United States of America]
Acme United Corporation - Form 483, 2020-03-13
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Acme United Corporation [Vancouver / United States of America]
BioSculptor Corporation - Form 483, 2020-03-13
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: BioSculptor Corporation [Hialeah / United States of America]
Steris Corporation - Form 483, 2020-03-13
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Steris Corporation [Mentor / United States of America]
Pacon Manufacturing Corporation - Form 483, 2020-03-13
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Pacon Manufacturing Corporation [Somerset / United States of America]
Pharma Nobis, LLC - Form 483R, 2020-04-17
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483 Response
Site Name: Pharma Nobis, LLC [Texarkana / United States of America]
Northwell Health Fertility - Form 483, 2020-03-12
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Northwell Health Fertility [Manhasset / United States of America]
One Umbilical Cord Lab, Inc. - Form 483, 2020-03-12
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: One Umbilical Cord Lab, Inc. [Richardson / United States of America]
Athenex Pharma Solutions, LLC - EIR, 2020-03-12
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: Athenex Pharma Solutions, LLC [Clarence / United States of America]
410 Medical Inc. - Form 483, 2020-03-12
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: 410 Medical Inc. [Durham / United States of America]
Syntenza Pharmaceuticals, LLC - Form 483, 2020-03-12
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Syntenza Pharmaceuticals, LLC [Minneapolis / United States of America]
Calvin Scott & Co., Inc. - Form 483, 2020-03-12
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Calvin Scott & Co., Inc. [Albuquerque / United States of America]
CHEMATICS, INC. - Form 483, 2020-03-12
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: CHEMATICS, INC. [Leesburg / United States of America]
Hemarus, LLC - Form 483, 2020-03-12
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Hemarus, LLC [Jacksonville / United States of America]
BALT USA, LLC - Form 483, 2020-03-12
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: BALT USA, LLC [Irvine / United States of America]
Karl Storz SE & Co. KG - Form 483, 2020-03-12
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Generics Bidco II LLC d/b/a Prinston Laboratories - EIR, 2020-03-11
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: Generics Bidco II LLC d/b/a Prinston Laboratories [Charlotte / United States of America]
La Vita Compounding Pharmacy, LLC - Form 483, 2020-03-11
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: La Vita Compounding Pharmacy, LLC [San Diego / United States of America]
Llorens Pharmaceutical International Division, Inc. - Form 483, 2020-03-11
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Llorens Pharmaceutical International Division, Inc. [Miami / United States of America]
Porex Corporation - EIR, 2020-03-11
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: Porex Corporation [Fairburn / United States of America]
Becton Dickinson Caribe LTD - Form 483, 2020-03-11
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Becton Dickinson Caribe LTD [Cayey / Puerto Rico]
Llorens Pharmaceutical International Division, Inc. - EIR, 2020-03-11
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: Llorens Pharmaceutical International Division, Inc. [Miami / United States of America]
Light Age, Inc. - Form 483, 2020-03-11
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Light Age, Inc. [Somerset / United States of America]
Vital Care of Dickson, LLC - Form 483, 2020-03-11
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Vital Care of Dickson, LLC [Dickson / United States of America]
Johnson & Johnson Consumer Inc. - EIR, 2020-03-11
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: Johnson & Johnson Consumer Inc. [Los Angeles / United States of America]
DSM Nutritional Products, LLC - EIR, 2020-03-11
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: DSM Nutritional Products, LLC [Fort Worth / United States of America]
Georgetown University IRB - Form 483, 2020-03-11
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Georgetown University IRB [Washington / United States of America]
Laboratory Corporation of America ViroMed Laboratories - EIR, 2020-03-10
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: Laboratory Corporation of America ViroMed Laboratories [Burlington / United States of America]
Maruho Plastic Solutions dba Relucent Plastic Solutions - Form 483, 2020-03-10
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Maruho Plastic Solutions dba Relucent Plastic Solutions [Erie / United States of America]
Caribe Holdings (Cayman) Co.ltd. DBA PuraCap Caribe - Form 483, 2020-03-10
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Caribe Holdings (Cayman) Co.ltd. DBA PuraCap Caribe [Higuillar / Puerto Rico]
Immunomedics, Inc. - EIR, 2020-03-10
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: Immunomedics, Inc. [Morris Plains / United States of America]
Kendrick Laboratories, Inc. - Form 483, 2020-03-10
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Kendrick Laboratories, Inc. [Madison / United States of America]
Immunomedics, Inc. - Form 483, 2020-03-10
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Immunomedics, Inc. [Morris Plains / United States of America]
Purcell International - EIR, 2020-03-17
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: Purcell International [Pleasant Hill / United States of America]
Coupler LLC - Form 483, 2020-03-10
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Coupler LLC [West Chester / United States of America]
Limonik Produce Inc - Form 483R, 2020-03-10
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483 Response
Site Name: Limonik Produce Inc [Mcallen / United States of America]
Unilever Manufacturing (US), Inc. - Form 483, 2020-03-10
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Unilever Manufacturing (US), Inc. [Jonesboro / United States of America]
Smart World LLC - EIR, 2020-03-10
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: Smart World LLC [Fremont / United States of America]
TruCore Distributors Inc - Form 483, 2020-03-10
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: TruCore Distributors Inc [Kings Park / United States of America]
Lifequest Creations LLC - Form 483, 2020-03-09
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Lifequest Creations LLC [Marietta / United States of America]
Hitachi America, Ltd., Particle Therapy Division - Form 483, 2020-03-09
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Hitachi America, Ltd., Particle Therapy Division [West Harrison / United States of America]
National Jewish Health - EIR, 2020-03-09
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: National Jewish Health [Denver / United States of America]
S&S X-Ray Products, Inc. - Form 483, 2020-03-09
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: S&S X-Ray Products, Inc. [Houston / United States of America]
Nurse Assist, LLC - EIR, 2020-03-23
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: Nurse Assist, LLC [Haltom City / United States of America]
National Jewish Health - Form 483, 2020-03-09
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: National Jewish Health [Denver / United States of America]
SOLARA ACTIVE PHARMA SCIENCES LIMITED - Form 483, 2020-03-07
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: SOLARA ACTIVE PHARMA SCIENCES LIMITED [Cuddalore Sub-District / India]
CORERX, INC. - EIR, 2020-03-06
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: CORERX, INC. [Clearwater / United States of America]
KBI Biopharma, Inc. - EIR, 2020-03-06
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: KBI Biopharma, Inc. [Boulder / United States of America]
Safetec of America Inc. - Form 483, 2020-03-06
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Safetec of America Inc. [Buffalo / United States of America]
Ames Goldsmith Corp - Form 483, 2020-03-06
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Ames Goldsmith Corp [Glens Falls / United States of America]
CORERX, INC. - Form 483R, 2020-03-27
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483 Response
Site Name: CORERX, INC. [Clearwater / United States of America]
Safetec of America Inc. - EIR, 2020-03-06
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: Safetec of America Inc. [Buffalo / United States of America]
Broekman Institute - Form 483, 2020-03-06
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Broekman Institute [Someren / Netherlands]
Empower Clinic Services LLC dba Empower Pharmacy - Form 483, 2020-03-06
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Empower Clinic Services LLC dba Empower Pharmacy [Houston / United States of America]
Vaupell Molding and Tooling, Inc. - Form 483, 2020-03-06
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Vaupell Molding and Tooling, Inc. [Agawam / United States of America]
The Harvard Drug Group - Form 483, 2020-03-06
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: The Harvard Drug Group [Livonia / United States of America]
Kyowa Kirin Pharmaceutical Research, Inc. - Form 483, 2020-03-06
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Kyowa Kirin Pharmaceutical Research, Inc. [La Jolla / United States of America]
CORERX, INC. - Form 483, 2020-03-06
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: CORERX, INC. [Clearwater / United States of America]
Naturich Cosmetique Labs - Form 483, 2020-03-06
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Naturich Cosmetique Labs [Garland / United States of America]
KBI Biopharma, Inc. - Form 483, 2020-03-06
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: KBI Biopharma, Inc. [Boulder / United States of America]
ONCORE - SAN MARCOS dba NEOTECH - Form 483, 2020-03-06
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: ONCORE - SAN MARCOS dba NEOTECH [San Marcos / United States of America]
Intuitive Surgical, Inc. - Form 483, 2020-03-06
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Intuitive Surgical, Inc. [Sunnyvale / United States of America]
Pan Medical U.S. Corp - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Pan Medical U.S. Corp [Largo / United States of America]
Lin Fertility Network, Inc. - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Lin Fertility Network, Inc. [Corona / United States of America]
Reactimex, SA de C.V. - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Reactimex, SA de C.V. [Bella Vista / Mexico]
Syenz Laboratory, LLC - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Syenz Laboratory, LLC [Norwood / United States of America]
MCKENNA LABS, INC. - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: MCKENNA LABS, INC. [Fullerton / United States of America]
Concert Medical, LLC - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Concert Medical, LLC [Norwell / United States of America]
MatOrtho Ltd - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: MatOrtho Ltd [Leatherhead / United Kingdom of Great Britain and Northern Ireland]
RLC Labs Inc. - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: RLC Labs Inc. [Phoenix / United States of America]
Cavex Holland B.V. - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Cavex Holland B.V. [Haarlem / Netherlands]
Dr Reddy's Laboratories Limited - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Dr Reddy's Laboratories Limited [Thripuraram / India]
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]
Creation Technologies Ltd - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Creation Technologies Ltd [Burnaby / Canada]
Adolfo A. Cueli MD - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Adolfo A. Cueli MD [Doral / United States of America]
ARUP Laboratories, Inc. - EIR, 2020-03-20
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: ARUP Laboratories, Inc. [Salt Lake City / United States of America]
Dot International - Form 483, 2020-03-05
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Dot International [Evanston / United States of America]
Thornton Industries, Inc. - Form 483, 2020-03-04
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Thornton Industries, Inc. [Morris / United States of America]
BioConnection B.V. - Form 483R, 2020-03-23
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483 Response
Site Name: BioConnection B.V. [Oss / Netherlands]
Shine & Pretty (USA), Corp - Form 483, 2020-03-04
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Shine & Pretty (USA), Corp [Camarillo / United States of America]
Merck Sharp & Dohme LLC - Form 483, 2020-03-04
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Merck Sharp & Dohme LLC [Elkton / United States of America]
Alltrista Plastics, LLC - Form 483, 2020-03-04
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Alltrista Plastics, LLC [Reedsville / United States of America]
The Community Blood Center, Inc. - Form 483, 2020-03-04
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: The Community Blood Center, Inc. [Appleton / United States of America]
Kalitec Direct, LLC - Form 483, 2020-03-04
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Kalitec Direct, LLC [Oviedo / United States of America]
Sigma-Aldrich Mfg LLC - Form 483, 2020-03-04
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Sigma-Aldrich Mfg LLC [Saint Louis / United States of America]
BioConnection B.V. - Form 483, 2020-03-04
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: BioConnection B.V. [Oss / Netherlands]
EUROMED, INC. - Form 483, 2020-03-03
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: EUROMED, INC. [Orangeburg / United States of America]
KUTOL PRODUCTS COMPANY - Form 483, 2020-03-03
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: KUTOL PRODUCTS COMPANY [Cincinnati / United States of America]
CANADIAN ANALYTICAL LABORATORIES INC - Form 483, 2020-03-03
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: CANADIAN ANALYTICAL LABORATORIES INC [Mississauga / Canada]
EUROMED, INC. - Form 483R, 2020-03-17
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483 Response
Site Name: EUROMED, INC. [Orangeburg / United States of America]
Shannon R. Schrader, M.D. - Form 483, 2020-03-03
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Shannon R. Schrader, M.D. [Houston / United States of America]
Charles River Laboratories - EIR, 2020-03-03
$1190 - Available for instant download
Issued On: March, 2020
Inspection Type: EIR
Site Name: Charles River Laboratories [Durham / United States of America]
Amerx Healthcare Corp - Form 483, 2020-03-03
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Amerx Healthcare Corp [Clearwater / United States of America]
Shady Grove Fertility - Form 483, 2020-03-02
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Shady Grove Fertility [Rockville / United States of America]
Forest Ambulatory Surgical Associates LLC - Form 483, 2020-03-02
$289 - Available for instant download
Issued On: March, 2020
Inspection Type: FDA 483
Site Name: Forest Ambulatory Surgical Associates LLC [San Jose / United States of America]
Jubilant Cadista Pharmaceuticals, Inc. - Form 483, 2020-02-28
$289 - Available for instant download
Issued On: February, 2020
Inspection Type: FDA 483
Site Name: Jubilant Cadista Pharmaceuticals, Inc. [Salisbury / United States of America]
Pinnacle Transplant Technologics, LLC - Form 483, 2020-02-28
$289 - Available for instant download
Issued On: February, 2020
Inspection Type: FDA 483
Site Name: Pinnacle Transplant Technologics, LLC [Phoenix / United States of America]
Macco Organiques, S.r.o. - Form 483R, 2020-03-13
$289 - Available for instant download
Issued On: February, 2020
Inspection Type: FDA 483 Response
Site Name: Macco Organiques, S.r.o. [Bruntál / Czechia]
Covidien, LP - Form 483, 2020-02-28
$289 - Available for instant download
Issued On: February, 2020
Inspection Type: FDA 483
Site Name: Covidien, LP [North Haven / United States of America]