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Pure Simple Products aka Northern Elderberry - Form 483, 2023-08-16
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Pure Simple Products aka Northern Elderberry [Traverse City / United States of America]
Applevalley Organics INC, Corporation - Form 483, 2023-08-16
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Applevalley Organics INC, Corporation [New York / United States of America]
Emergent Biodefense Operations Lansing LLC - Form 483, 2023-08-16
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Emergent Biodefense Operations Lansing LLC [Canton / United States of America]
Green Sprouts - Form 483, 2023-08-16
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Green Sprouts [Asheville / United States of America]
AMMAN PHARMACEUTICAL INDUSTRIES - Form 483, 2023-08-15
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Spinergy, Inc (SM Power LLC) - Form 483, 2023-08-15
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Spinergy, Inc (SM Power LLC) [San Marcos / United States of America]
Glens Falls Hospital IRB - Form 483, 2023-08-14
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Glens Falls Hospital IRB [Glens Falls / 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]
ABS Corporation - Form 483, 2023-08-11
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: ABS Corporation [Omaha / United States of America]
Henan Dongtai Pharm Co., Ltd. - EIR, 2024-01-17
$1190 - Available for instant download
Issued On: August, 2023
Inspection Type: EIR
Sojitz Corporation of America - Form 483, 2023-08-11
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Sojitz Corporation of America [New York / United States of America]
Apex International Mfg., LLC - Form 483, 2023-08-11
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Apex International Mfg., LLC [Chaska / United States of America]
PT Solutions LLC - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: PT Solutions LLC [Brunswick / United States of America]
Coupler LLC - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Coupler LLC [West Chester / United States of America]
Cangene BioPharma, LLC - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Cangene BioPharma, LLC [Baltimore / United States of America]
Dendreon Pharmaceuticals LLC - Form 483, 2023-08-10
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Dendreon Pharmaceuticals LLC [Seal Beach / United States of America]
Pharmatech Inc. - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Pharmatech Inc. [Lindon / United States of America]
Veterans Administration Hospital Blood Bank - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Veterans Administration Hospital Blood Bank [Fort Harrison / United States of America]
Anika Therapeutics Inc - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Anika Therapeutics Inc [Bedford / United States of America]
California Center for Reproductive Health - Form 483, 2023-08-09
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: California Center for Reproductive Health [Encino / United States of America]
Burpee Materials Technology, LLC - Form 483, 2023-08-08
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Burpee Materials Technology, LLC [Eatontown / United States of America]
Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) - Form 483, 2023-08-08
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) [Pingshan District / China]
Cyclomedica Australia Pty Limited - Form 483, 2023-08-08
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Cyclomedica Australia Pty Limited [Sydney / Australia]
Command Medical Products, Inc. - Form 483, 2023-08-08
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Command Medical Products, Inc. [Ormond Beach / United States of America]
Akeso Biopharma Co., Ltd. - Form 483, 2023-08-07
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Prime Lab, LLC - Form 483, 2023-09-14
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Prime Lab, LLC [Sabanetas / Puerto Rico]
Andrew C. Siesennop, MD - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Andrew C. Siesennop, MD [Boston / United States of America]
Ensemble Orthopedics, Inc. - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Ensemble Orthopedics, Inc. [West Lake Hills / United States of America]
Sri Krishna Pharmaceuticals Limited - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Sri Krishna Pharmaceuticals Limited [Hyderabad / India]
Asept Pak Inc. - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Asept Pak Inc. [Malone / United States of America]
Mark A. Stein, Ph.D. - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Mark A. Stein, Ph.D. [Seattle / United States of America]
TEH SENG PHARMACEUTICAL MFG. CO., LTD. 3RD PLANT - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: TEH SENG PHARMACEUTICAL MFG. CO., LTD. 3RD PLANT [Yongkang District / Taiwan]
Roslin Cell Therapies Limited - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Roslin Cell Therapies Limited [Edinburgh / United Kingdom of Great Britain and Northern Ireland]
Mead Johnson (Asia Pacific) Pte. Ltd. - EIR, 2023-11-05
$1190 - Available for instant download
Issued On: August, 2023
Inspection Type: EIR
Site Name: Mead Johnson (Asia Pacific) Pte. Ltd. [Singapore / Singapore]
MARKSANS PHARMA LIMITED - Form 483, 2023-08-04
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: MARKSANS PHARMA LIMITED [Mormugao / India]
Inopak Ltd - Form 483, 2023-08-03
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Hygeia II Medical Group, Inc. - Form 483, 2023-08-02
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Hygeia II Medical Group, Inc. [Carlsbad / United States of America]
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma - Form 483, 2023-08-02
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Reciprocal Labs Corporation - Form 483, 2023-08-02
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Reciprocal Labs Corporation [Madison / United States of America]
Sovereign Pharmaceuticals, LLC - Form 483, 2023-08-02
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Sovereign Pharmaceuticals, LLC [Fort Worth / United States of America]
Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. - Form 483, 2023-08-01
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. [Jinhua / China]
Swabplus, L.P. - Form 483, 2023-08-01
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: Swabplus, L.P. [Rancho Cucamonga / United States of America]
SpineSmith Holdings, LLC - Form 483, 2023-08-01
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: SpineSmith Holdings, LLC [Austin / United States of America]
KGR Distribution Corp. - Form 483, 2023-08-01
$289 - Available for instant download
Issued On: August, 2023
Inspection Type: FDA 483
Site Name: KGR Distribution Corp. [Passaic / United States of America]
Central Admixture Pharmacy Services, Inc. - Form 483, 2023-07-31
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Central Admixture Pharmacy Services, Inc. [Phoenix / United States of America]
Saint-Gobain Perofrmance Plastics, Inc. - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Saint-Gobain Perofrmance Plastics, Inc. [Portage / United States of America]
APOTHECON PHARMACEUTICALS PRIVATE LIMITED - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: APOTHECON PHARMACEUTICALS PRIVATE LIMITED [Padra / India]
Insulet Corporation - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Insulet Corporation [Acton / United States of America]
Pelex Medical of Texas - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Pelex Medical of Texas [Lubbock / United States of America]
Zoetis Manufacturing & Research Spain, S.L. - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Zoetis Manufacturing & Research Spain, S.L. [La Vall De Bianya / Spain]
Virbac Corporation - Form 483, 2023-07-28
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Virbac Corporation [Bridgeton / United States of America]
Aeropres Corp - Form 483, 2023-07-27
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Aeropres Corp [Sibley / United States of America]
Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery - Form 483, 2023-07-26
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
POET Corning Bioprocessing LLC - Form 483, 2023-07-26
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: POET Corning Bioprocessing LLC [Corning / United States of America]
Kofinas Fertility Group - Form 483, 2023-07-25
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Kofinas Fertility Group [New York / United States of America]
Novo Nordisk US Bio Production Inc. - Form 483, 2023-07-25
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Novo Nordisk US Bio Production Inc. [West Lebanon / United States of America]
POET Bioprocessing-Emmetsburg LLC - Form 483, 2023-07-25
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: POET Bioprocessing-Emmetsburg LLC [Emmetsburg / United States of America]
Oximeter Plus, Inc - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Oximeter Plus, Inc [Roslyn Heights / United States of America]
PBM Nutritionals, LLC - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: PBM Nutritionals, LLC [Covington / United States of America]
Aurobindo Pharma Limited - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Aurobindo Pharma Limited [Hyderabad / India]
Catalent Pharma Solutions, LLC - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Catalent Pharma Solutions, LLC [Saint Petersburg / United States of America]
Vericel Corporation - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Vericel Corporation [Cambridge / United States of America]
POET Biorefining-Hanlontown - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: POET Biorefining-Hanlontown [Hanlontown / United States of America]
Cosette Pharmaceuticals NC Laboratories, LLC - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Cosette Pharmaceuticals NC Laboratories, LLC [Lincolnton / United States of America]
S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED - Form 483, 2023-07-21
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED [Bueng / Thailand]
Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API) - EIR, 2025-05-13
$1190 - Available for instant download
Issued On: July, 2023
Inspection Type: EIR
Site Name: Zhejiang Xianju Pharmaceutical Co. Ltd.(Yangfu API) [Xianju / China]
Precision Align LLC - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Precision Align LLC [Fort Lauderdale / United States of America]
SPINE INNOVATION, LLC - Form 483, 2023-07-20
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: SPINE INNOVATION, LLC [Del Mar / United States of America]
Inmar Supply Chain Solutions, LLC - Form 483, 2023-07-19
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Inmar Supply Chain Solutions, LLC [Arlington / United States of America]
Glaukos Corporation - EIR, 2023-08-01
$1190 - Available for instant download
Issued On: July, 2023
Inspection Type: EIR
Site Name: Glaukos Corporation [San Clemente / United States of America]
Teva API India Private Ltd. - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Whele LLC DBA Perch - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Whele LLC DBA Perch [Boston / United States of America]
Product Packaging West, Inc. - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Product Packaging West, Inc. [North Hollywood / United States of America]
GE Healthcare - Repair Operations Center - Form 483, 2023-07-18
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: GE Healthcare - Repair Operations Center [Oak Creek / United States of America]
A-OX WELDING SUPPLY CO., INC. - Form 483, 2023-07-17
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: A-OX WELDING SUPPLY CO., INC. [Sioux Falls / United States of America]
Preservation Solutions, Inc. - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Preservation Solutions, Inc. [Elkhorn / United States of America]
Altasciences Preclinical Seattle, LLC - EIR, 2023-08-22
$1190 - Available for instant download
Issued On: July, 2023
Inspection Type: EIR
Site Name: Altasciences Preclinical Seattle, LLC [Everett / United States of America]
Sentara Enterprises dba Sentara Infusion Services (Blue Ridge) - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Eco Lips, Inc. - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Eco Lips, Inc. [Cedar Rapids / United States of America]
Aspire Pharmaceuticals Inc. - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Aspire Pharmaceuticals Inc. [Somerset / United States of America]
Gland Pharma Limited - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Gland Pharma Limited [Hyderabad / India]
ST Pharm Co., Ltd. - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: ST Pharm Co., Ltd. [Danwon-Gu / Korea (Republic of)]
Altasciences Preclinical Seattle, LLC - Form 483, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Altasciences Preclinical Seattle, LLC [Everett / United States of America]
Syfrett Feed Company, Inc. - Form 483, 2023-07-13
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Syfrett Feed Company, Inc. [Okeechobee / United States of America]
PT Genie LLC - Form 483, 2023-07-13
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: PT Genie LLC [Orlando / United States of America]
Novo Nordisk Pharmaceutical Industries, LP - Form 483, 2023-07-13
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Novo Nordisk Pharmaceutical Industries, LP [Clayton / United States of America]
Medical Products Laboratories, Inc. - Form 483, 2023-07-13
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Medical Products Laboratories, Inc. [Philadelphia / United States of America]
Novo Nordisk Pharmaceutical Industries, LP - EIR, 2023-08-29
$1190 - Available for instant download
Issued On: July, 2023
Inspection Type: EIR
Site Name: Novo Nordisk Pharmaceutical Industries, LP [Clayton / United States of America]
Iovance Biotherapeutics, Inc. - EIR, 2023-07-13
$1190 - Available for instant download
Issued On: July, 2023
Inspection Type: EIR
Site Name: Iovance Biotherapeutics, Inc. [San Carlos / United States of America]
Sun Pharmaceutical Medicare Limited - Form 483, 2023-07-13
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Sun Pharmaceutical Medicare Limited [Halol / India]
Medline Industries, LP (f/k/a Medline Industries, Inc.) - Form 483, 2023-07-12
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Medline Industries, LP (f/k/a Medline Industries, Inc.) [Mundelein / United States of America]
Aspire Fertility Institute Dallas - Form 483, 2023-07-12
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Aspire Fertility Institute Dallas [Addison / United States of America]
Cincinnati Childrens Hosp Med Center Div of Gynecology - Form 483, 2023-07-12
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Cincinnati Childrens Hosp Med Center Div of Gynecology [Cincinnati / United States of America]
Boston Medical Products, Inc. - Form 483, 2023-07-12
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Boston Medical Products, Inc. [Shrewsbury / United States of America]
Mars PetCare US, Inc. - EIR, 2023-07-31
$1190 - Available for instant download
Issued On: July, 2023
Inspection Type: EIR
Site Name: Mars PetCare US, Inc. [Aurora / United States of America]
LUPIN LIMITED - Form 483, 2023-07-11
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: LUPIN LIMITED [Nagpur / India]
Carnegie Pharmaceuticals, LLC - Form 483, 2023-07-07
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Carnegie Pharmaceuticals, LLC [Delran / United States of America]
Surgery Pharmacy Services Inc - Form 483R, 2023-07-14
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483 Response
Site Name: Surgery Pharmacy Services Inc [Chattanooga / United States of America]
Avanti Polar Lipids - Form 483, 2023-07-07
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Avanti Polar Lipids [Alabaster / United States of America]
Surgery Pharmacy Services Inc - Form 483, 2023-07-07
$289 - Available for instant download
Issued On: July, 2023
Inspection Type: FDA 483
Site Name: Surgery Pharmacy Services Inc [Chattanooga / United States of America]