Recently Published FDA Form 483s

Nurse Assist, LLC [Haltom City / United States of America]

Inspection End Date: September 21, 2023

FEI: 3002695476

Location: HALTOM CITY, TX, United States of America

Investigators: Jacey Roy, Terri E Gibson, Christine I Shaw

Arcamed LLC [Indianapolis / United States of America]

Inspection End Date: September 21, 2023

FEI: 3010622588

Location: INDIANAPOLIS, IN, United States of America

Investigators: Debara R Reese

Iridex Corporation [Mountain View / United States of America]

Inspection End Date: September 20, 2023

FEI: 2939653

Location: MOUNTAIN VIEW, CA, United States of America

Investigators: Brittany D Mccracken, Maida Henesian (NMI)

Ajinomoto Althea, Inc. [San Diego / United States of America]

Inspection End Date: September 20, 2023

FEI: 3004575449

Location: SAN DIEGO, CALIFORNIA, United States of America

Investigators: Taichun Qin, PhD, Cassandra L Abellard, Yi Wang, PhD

McNeil Healthcare LLC. [Rico / United States of America]

Inspection End Date: September 20, 2023

FEI: 2650141

Location: RICO, , United States of America

Investigators: Jose E Melendez, DDC, Marian E Ramirez

Ultra Seal Corporation [York / United States of America]

Inspection End Date: September 20, 2023

FEI: 1317759

Location: YORK, NY, United States of America

Investigators: Syeda N Mahazabin, Tanya R Syffrard, Ruben C Quintana

Nature's Pharmacy, LLC [Bloomer / United States of America]

Inspection End Date: September 20, 2023

FEI: 3011124037

Location: BLOOMER, WI, United States of America

Investigators: Jesse P Romenesko

Juno Therapeutics, Inc. [Bothell / United States of America]

Inspection End Date: September 20, 2023

FEI: 3011834594

Location: BOTHELL, WA, United States of America

Investigators: Christopher R Czajka, Michael S Araneta

ARG LABORATORIES INC [Dallas / United States of America]

Inspection End Date: September 20, 2023

FEI: 3002556034

Location: DALLAS, TX, United States of America

Investigators: Shelby N Turner, Michelle A Krayer

Dercher Enterprises, Inc., DBA Gordon Laboratories [Upper Darby / United States of America]

Inspection End Date: September 20, 2023

FEI: 2510734

Location: UPPER DARBY, PA, United States of America

Investigators: Anastasia M Shields, Juanita P Versace

Pine Pharmaceuticals, LLC [Tonawanda / United States of America]

Inspection End Date: September 19, 2023

FEI: 3010943533

Location: TONAWANDA, NY, United States of America

Investigators: Tekalign Wondimu

First Source Inc [Rochester / United States of America]

Inspection End Date: September 19, 2023

FEI: 3004063527

Location: ROCHESTER, NY, United States of America

Investigators: Matthew D Schnittker

InvaGen Pharmaceuticals, Inc [Central Islip New York / United States of America]

Inspection End Date: September 19, 2023

FEI: 3012696190

Location: CENTRAL ISLIP NEW YORK, NY, United States of America

Investigators: Bijoy Panicker, Amatul H Marium, Karishma G Gopaul

Augustine Temperature Management, LLC [Minneapolis / United States of America]

Inspection End Date: September 19, 2023

FEI: 3005857264

Location: MINNEAPOLIS, MN, United States of America

Investigators: Benjamin W Anderson

Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC [Andover / United States of America]

Inspection End Date: September 19, 2023

FEI: 1222181

Location: ANDOVER, MASSACHUSETTS, United States of America

Investigators: Brently S Collins, Brentley S Collins, Gene D Arcy, Priscilla M Pastrana

AstraZeneca Pharmaceuticals LP [Mount Vernon / United States of America]

Inspection End Date: September 19, 2023

FEI: 1825662

Location: MOUNT VERNON, IN, United States of America

Investigators: Joseph A Piechocki

Tech Medical Services, Inc [Nixa / United States of America]

Inspection End Date: September 19, 2023

FEI: 3001003398

Location: NIXA, MO, United States of America

Investigators: Eric C Fox

APL HEALTHCARE LIMITED [India / India]

Inspection End Date: September 19, 2023

FEI: 3011895410

Location: INDIA, ANDHRA PRADESH, India

Investigators: Kellia N Hicks

SpecGx LLC [Webster Groves / United States of America]

Inspection End Date: September 18, 2023

FEI: 3005275960

Location: WEBSTER GROVES, MO, United States of America

Investigators: Monica Murie, Robert J Ham, Monica E Murie

Fareva Richmond, Inc. [Virginia / United States of America]

Inspection End Date: September 18, 2023

FEI: 1120199

Location: VIRGINIA, VA, United States of America

Investigators: Karen A Briggs

Isomedix Operations Inc [Libertyville / United States of America]

Inspection End Date: September 18, 2023

FEI: 3003015552

Location: LIBERTYVILLE, IL, United States of America

Investigators: Nibin Varghese, MS, Roshni J Patel

Kentucky Blood Center Inc [Lexington / United States of America]

Inspection End Date: September 18, 2023

FEI: 1070402

Location: LEXINGTON, KY, United States of America

Investigators: Jennifer L Sheehan

Isomedix Operations Inc. [Minneapolis / United States of America]

Inspection End Date: September 15, 2023

FEI: 2183744

Location: MINNEAPOLIS, MN, United States of America

Investigators: Lori B Wikstrom

Agile Devices, Inc. [Newton Center / United States of America]

Inspection End Date: September 15, 2023

FEI: 3023167283

Location: NEWTON CENTER, MA, United States of America

Investigators: James P Finn

Eli Lilly and Company [Indianapolis / United States of America]

Inspection End Date: September 15, 2023

FEI: 1819470

Location: INDIANAPOLIS, IN, United States of America

Investigators: Jennifer A Kemp, Dina A Tallman

RLC Labs Inc. [Phoenix / United States of America]

Inspection End Date: September 15, 2023

FEI: 3002523846

Location: PHOENIX, AZ, United States of America

Investigators: Carrie A Hughes, Cecilia H Kieu

BioStem Life Sciences [Pompano Beach / United States of America]

Inspection End Date: September 15, 2023

FEI: 3013239405

Location: POMPANO BEACH, FL, United States of America

Investigators: Ivan E Reyes, Sergio E Delgado, Annette Melendez

Rinovum Subsidiary 2 LLC [Monroeville / United States of America]

Inspection End Date: September 15, 2023

FEI: 3015417614

Location: MONROEVILLE, PA, United States of America

Investigators: Dennis R Hock

LLOYD, Inc. of Iowa [Shenandoah / United States of America]

Inspection End Date: September 15, 2023

FEI: 1911196

Location: SHENANDOAH, IA, United States of America

Investigators: Soyinka S Eneng, Michele Perry Williams

Central Glass CO., LTD. [Ube / Japan]

Inspection End Date: September 15, 2023

FEI: 3002806649

Location: UBE, YAMAGUCHI, Japan

Investigators: Teresa I Navas

North Mississippi Health Services IRB [Tupelo / United States of America]

Inspection End Date: September 15, 2023

FEI: 3006068786

Location: TUPELO, MS, United States of America

Investigators: Kellie R Riggs

MIE America, Inc. [Elk Grove Village / United States of America]

Inspection End Date: September 14, 2023

FEI: 3000210013

Location: ELK GROVE VILLAGE, IL, United States of America

Investigators: Jesse A Vazquez

Mettler Electronics Corp [Anaheim / United States of America]

Inspection End Date: September 14, 2023

FEI: 2013558

Location: ANAHEIM, CA, United States of America

Investigators: Marlo Ianm Alintanahin

Vinay Sikand, M.D. [Toms River / United States of America]

Inspection End Date: September 14, 2023

FEI: 3027285712

Location: TOMS RIVER, NJ, United States of America

Investigators: Mayar M Mussa, Michael Serrano

Select Corporation [Carrollton / United States of America]

Inspection End Date: September 14, 2023

FEI: 3003727136

Location: CARROLLTON, TX, United States of America

Investigators: Timothy H Vo

Ionetix Corporation [El Paso / United States of America]

Inspection End Date: September 14, 2023

FEI: 3016458643

Location: EL PASO, TX, United States of America

Investigators: Demario L Walls, Margaret M Annes

Immersivetouch Inc [Chicago / United States of America]

Inspection End Date: September 14, 2023

FEI: 3014833795

Location: CHICAGO, IL, United States of America

Investigators: Natasha R Johnson

Computer Programs & Systems Inc [Mobile / United States of America]

Inspection End Date: September 13, 2023

FEI: 3004120479

Location: MOBILE, AL, United States of America

Investigators: Cody D Rickman

Inventex Medical [Niles / United States of America]

Inspection End Date: September 13, 2023

FEI: 3009495876

Location: NILES, IL, United States of America

Investigators: Nydia E Colon

Biomat USA, Inc [City Of Industry / United States of America]

Inspection End Date: September 13, 2023

FEI: 3005488132

Location: CITY OF INDUSTRY, CA, United States of America

Investigators: Kelvin Cheung

Vacumed, Div of Vacumetrics Inc [Ventura / United States of America]

Inspection End Date: September 13, 2023

FEI: 2023529

Location: VENTURA, CA, United States of America

Investigators: Sarah A Hassas

Banyan USA LLC [Hauppauge / United States of America]

Inspection End Date: September 12, 2023

FEI: 3020737798

Location: HAUPPAUGE, NY, United States of America

Investigators: Andrew J Garufi

Medwaves Inc [San Diego / United States of America]

Inspection End Date: September 12, 2023

FEI: 3005382058

Location: SAN DIEGO, CA, United States of America

Investigators: Jenny L Chisem

Life Recovery Systems HD, LLC [Kinnelon / United States of America]

Inspection End Date: September 11, 2023

FEI: 3006059109

Location: KINNELON, NJ, United States of America

Investigators: Jonathan Ho, Naakesh N Gomanie, Matthew W Kyle

PETNET SOLUTIONS, INC. [Phoenix / United States of America]

Inspection End Date: September 8, 2023

FEI: 3007134238

Location: PHOENIX, AZ, United States of America

Investigators: Nicholas L Hunt, Cecilia H Kieu

Strive Pharmacy Texas LLC dba Strive Pharmacy [Boerne / United States of America]

Inspection End Date: September 8, 2023

FEI: 3015826784

Location: BOERNE, TX, United States of America

Investigators: Camerson E Moore

Joel Solis, MD [Mcallen / United States of America]

Inspection End Date: September 8, 2023

FEI: 3017709576

Location: MCALLEN, TX, United States of America

Investigators: Lisa A Doyle

Alcon Singapore Manufacturing Pte. Ltd. [Singapore / Singapore]

Inspection End Date: September 8, 2023

FEI: 3010372291

Location: SINGAPORE, , Singapore

Investigators: Dogbeda F Mackenzie, Jeffrey P Raimondi

Jennifer W. Leiding M.D. [Seminole / United States of America]

Inspection End Date: September 8, 2023

FEI: 3027115677

Location: SEMINOLE, FL, United States of America

Investigators: Valerie L Kelesyan, LCDR Angelica M Chica

DUSA Pharmaceuticals, Inc. [Billerica / United States of America]

Inspection End Date: September 8, 2023

FEI: 3002513708

Location: BILLERICA, MA, United States of America

Investigators: Sunita Pandey

ASO Pharmaceutical Co.,ltd. [Kumamoto / Japan]

Inspection End Date: September 8, 2023

FEI: 1000414460

Location: KUMAMOTO, , Japan

Investigators: Teresa I Navas

Naval Medical Center Camp Lejeune [Lejeune / United States of America]

Inspection End Date: September 8, 2023

FEI: 1076942

Location: LEJEUNE, NC, United States of America

Investigators: Marla A Cassidy

Medco Manufacturing [Spring / United States of America]

Inspection End Date: September 7, 2023

FEI: 3001451796

Location: SPRING, TX, United States of America

Investigators: Jocelyn C Turner

Timothy F. Burns, MD, PhD [Pittsburgh / United States of America]

Inspection End Date: September 7, 2023

FEI: 3027505630

Location: PITTSBURGH, PA, United States of America

Investigators: Cythia L Rakestraw, Cynthia L Rakestraw

American Red Cross [Virginia Beach / United States of America]

Inspection End Date: September 7, 2023

FEI: 1000122847

Location: VIRGINIA BEACH, VA, United States of America

Investigators: Kenneth L Smalls

Fresenius Kabi USA, LLC [North Andover / United States of America]

Inspection End Date: September 7, 2023

FEI: 3014732157

Location: NORTH ANDOVER, MA, United States of America

Investigators: Sara M Onyango

McPherson Enterprises, Inc., dba Implantable Devices [Pinellas Park / United States of America]

Inspection End Date: September 6, 2023

FEI: 1033972

Location: PINELLAS PARK, FL, United States of America

Investigators: Alex J Wild

CIT Ortho [Westlake / United States of America]

Inspection End Date: September 5, 2023

FEI: 3015259710

Location: WESTLAKE, OH, United States of America

Investigators: Laureen M Geniusz

B & D Dental Corp. [West Valley City / United States of America]

Inspection End Date: September 5, 2023

FEI: 3008190898

Location: WEST VALLEY CITY, UT, United States of America

Investigators: James R Montero

The Sperm and Embryo Bank of New Jersey, Inc. [Mountainside / United States of America]

Inspection End Date: September 5, 2023

FEI: 3003945123

Location: MOUNTAINSIDE, NJ, United States of America

Investigators: Amy Kim

Prime Enterprises [Florida / United States of America]

Inspection End Date: September 1, 2023

FEI: 1036626

Location: FLORIDA, FL, United States of America

Investigators: Martrice A Packer, Simone E Pitts

CMP Pharma, Inc. [Farmville / United States of America]

Inspection End Date: September 1, 2023

FEI: 1050589

Location: FARMVILLE, NORTH CAROLINA NC, United States of America

Investigators: Suzanne N Vallez

APN Health LLC [Waukesha / United States of America]

Inspection End Date: September 1, 2023

FEI: 3014282601

Location: WAUKESHA, WI, United States of America

Investigators: Mildred J Tures, Michelle J Glembin

Samsung Biologics Co., Ltd. [Incheon / -]

Inspection End Date: September 1, 2023

FEI: 3010479596

Location: INCHEON, ,

Investigators: Wayne E Seifert, Dogbeda F Mackenzie, Hyung Yul Lee, Jacek Cieslak, PhD, Jeffrey P Raimondi

ARCADLAB LLC [West Palm Beach / United States of America]

Inspection End Date: September 1, 2023

FEI: 3014531454

Location: WEST PALM BEACH, FL, United States of America

Investigators: Gisselle I Sensebe

Safecor Health, LLC [Columbus Ohio / United States of America]

Inspection End Date: September 1, 2023

FEI: 3008841077

Location: COLUMBUS OHIO, OH, United States of America

Investigators: Geoffrey K Kilili

Brian B. Borg, M.D. [Metairie / United States of America]

Inspection End Date: September 1, 2023

FEI: 3026970873

Location: METAIRIE, LA, United States of America

Investigators: Kellie R Riggs, Christopher M Jeffers

Aveva Drug Delivery Systems Inc. [Florida / United States of America]

Inspection End Date: September 1, 2023

FEI: 1000307689

Location: FLORIDA, FL, United States of America

Investigators: Steven A Brettler

South Bend Medical Foundation, Inc. [South Bend / United States of America]

Inspection End Date: September 1, 2023

FEI: 1870308

Location: SOUTH BEND, IN, United States of America

Investigators: Kaarin M Slotte

Oishi Koseido Co., Ltd. [Tosu Saga / Japan]

Inspection End Date: September 1, 2023

FEI: 3010166685

Location: TOSU SAGA, , Japan

Investigators: Teresa I Navas

Biomic Sciences, LLC dba ION Intelligence of Nature [Charlottesville / United States of America]

Inspection End Date: August 31, 2023

FEI: 3012139887

Location: CHARLOTTESVILLE, VA, United States of America

Investigators: Siobhan G Taylor, Karen A Spencer

Accuon Labs Inc. [Hauppauge New York / United States of America]

Inspection End Date: August 31, 2023

FEI: 3014660411

Location: HAUPPAUGE NEW YORK, NY, United States of America

Investigators: Karishma G Gopaul

Dynavision Global Holdings LLC [Cincinnati / United States of America]

Inspection End Date: August 31, 2023

FEI: 3010197315

Location: CINCINNATI, OH, United States of America

Investigators: Teresa K Kastner

O3UV, LLC [Grand Ledge / United States of America]

Inspection End Date: August 31, 2023

FEI: 3027918571

Location: GRAND LEDGE, MI, United States of America

Investigators: Thomas A Peter, Felicia E Hinojosa

Carrollclean, LLC [Garland / United States of America]

Inspection End Date: August 31, 2023

FEI: 1611690

Location: GARLAND, TX, United States of America

Investigators: Kevin T Nguyen

Pure Source, LLC [Florida / United States of America]

Inspection End Date: August 31, 2023

FEI: 3002754162

Location: FLORIDA, FL, United States of America

Investigators: Ronald Ifraimov

SunMed Holdings, LLC [Grand Rapids / United States of America]

Inspection End Date: August 30, 2023

FEI: 1314417

Location: GRAND RAPIDS, MI, United States of America

Investigators: Suyang Qin, Melina Lrodriguez Upton

Brammer Bio MA, LLC [Cambridge / United States of America]

Inspection End Date: August 30, 2023

FEI: 3013417996

Location: CAMBRIDGE, MASSACHUSETTS, United States of America

Investigators: Lewis K Antwi, Thai D Truong

Cardionics, Inc [Webster / United States of America]

Inspection End Date: August 30, 2023

FEI: 1629623

Location: WEBSTER, TX, United States of America

Investigators: Katlin N Stubbs

Labcorp Early Development Laboratories, Inc. [Madison / United States of America]

Inspection End Date: August 30, 2023

FEI: 2128592

Location: MADISON, WI, United States of America

Investigators: Denise L Burosh, Dina A Tallman

Lifeaire Systems [Allentown / United States of America]

Inspection End Date: August 29, 2023

FEI: 3009065312

Location: ALLENTOWN, PA, United States of America

Investigators: Nadia R Barreda

APPCO PHARMA LLC [Jersey / United States of America]

Inspection End Date: August 29, 2023

FEI: 3010014758

Location: JERSEY, NJ, United States of America

Investigators: Alice S Tsao, Ankur C Patel

CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED [India / India]

Inspection End Date: August 29, 2023

FEI: 3015283219

Location: INDIA, TELANGANA, India

Investigators: Lillian S Wu, Nicole E Knowlton

SMITHWORKS, INC. [Lindale / United States of America]

Inspection End Date: August 29, 2023

FEI: 3005730406

Location: LINDALE, TX, United States of America

Investigators: Ellen J Tave

MacroGenics, Inc [Rockville / United States of America]

Inspection End Date: August 28, 2023

FEI: 3010195035

Location: ROCKVILLE, MARYLAND MD, United States of America

Investigators: David A Oluwo

North Coast Medical Inc [Morgan Hill / United States of America]

Inspection End Date: August 28, 2023

FEI: 1000124207

Location: MORGAN HILL, CA, United States of America

Investigators: Jeffrey S Buckser

Neos Therapeutics, LP [Grand Prairie / United States of America]

Inspection End Date: August 25, 2023

FEI: 3000205839

Location: GRAND PRAIRIE, TX, United States of America

Investigators: Rodney L Tinzie, Margaret M Annes

Miguelangelo J. Perez-Cruet, M.D., M.S. [Waterford Township / United States of America]

Inspection End Date: August 25, 2023

FEI: 3007772984

Location: WATERFORD TOWNSHIP, MI, United States of America

Investigators: Corrine M Carter, Jennifer A Kemp

Paul Sorajja, M.D., Clinical Investigator [Minneapolis / United States of America]

Inspection End Date: August 25, 2023

FEI: 3015054234

Location: MINNEAPOLIS, MN, United States of America

Investigators: Sharon L Matson

Berkshire Sterile Manufacturing, Inc. [Lee Massachusetts / United States of America]

Inspection End Date: August 25, 2023

FEI: 3012144557

Location: LEE MASSACHUSETTS, MA, United States of America

Investigators: Jonathan G Matrisciano

Virak Orthopedics LLC [Harrison / United States of America]

Inspection End Date: August 25, 2023

FEI: 3010860227

Location: HARRISON, NJ, United States of America

Investigators: Monica L Gutierrez

GPI USA, Inc. [Houston / United States of America]

Inspection End Date: August 25, 2023

FEI: 3017199812

Location: HOUSTON, TX, United States of America

Investigators: Lesley Maep Lutao, Creighton T Tuzon

Central Admixture Pharmacy Services Inc [San Diego / United States of America]

Inspection End Date: August 25, 2023

FEI: 3004378804

Location: SAN DIEGO, CA, United States of America

Investigators: Jolanna A Norton, Xiaohui Shen, Doan N Singh, Rachel C Stanton

Photonicare Inc [Champaign / United States of America]

Inspection End Date: August 25, 2023

FEI: 3016597890

Location: CHAMPAIGN, IL, United States of America

Investigators: Jesse A Vazquez

TAYCA CORPORATION [- / Japan]

Inspection End Date: August 25, 2023

FEI: 3002777902

Location: , , Japan

Investigators: Gavin T Cua

Bleep, LLC [Chapel Hill / United States of America]

Inspection End Date: August 25, 2023

FEI: 3015436853

Location: CHAPEL HILL, NC, United States of America

Investigators: Monica Cburgos Garcia

Biomerics LLC [Brooklyn Park / United States of America]

Inspection End Date: August 25, 2023

FEI: 3012159165

Location: BROOKLYN PARK, MN, United States of America

Investigators: Christina L Bigham, Benjamin E Bowen

Fairfax Cryobank, Inc. [Fairfax / United States of America]

Inspection End Date: August 24, 2023

FEI: 3004731690

Location: FAIRFAX, VA, United States of America

Investigators: La Tasha M Gunter

Paramesh Banerji Life Sciences LLC [Jersey / United States of America]

Inspection End Date: August 24, 2023

FEI: 3011020725

Location: JERSEY, NJ, United States of America

Investigators: Helen Verdel

Fresenius Kabi USA, LLC [Melrose Park Illinois / United States of America]

Inspection End Date: August 24, 2023

FEI: 1450022

Location: MELROSE PARK ILLINOIS, IL, United States of America

Investigators: Andrew J Barrowcliff, Alan M Barker, Nicholas J Presto, Chad W Rice

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