Recently Published FDA Form 483s

Viant AS&O Holdings, LLC [Orchard Park / United States of America]

Inspection End Date: October 27, 2023

FEI: 1000120314

Location: ORCHARD PARK, NY, United States of America

Investigators: Matthew D Schnittker

Mary Kay Inc. [Lewisville / United States of America]

Inspection End Date: October 27, 2023

FEI: 3014970187

Location: LEWISVILLE, TX, United States of America

Investigators: Kevin T Nguyen

Novartis Manufacturing LLC [Indianapolis / United States of America]

Inspection End Date: October 27, 2023

FEI: 3019881323

Location: INDIANAPOLIS, IN, United States of America

Investigators: Michele L Glendenning, Geoffrey K Kilili

Quotient Sciences - Philadelphia, LLC [Garnet Valley Pennsylvania / United States of America]

Inspection End Date: October 27, 2023

FEI: 3014679374

Location: GARNET VALLEY PENNSYLVANIA, PA, United States of America

Investigators: Brandy N Lepage

Greater Baltimore Medical Center [Towson / United States of America]

Inspection End Date: October 26, 2023

FEI: 1173170

Location: TOWSON, MD, United States of America

Investigators: Richard J Bashay

Grafton Medical Alliance [Burr Ridge / United States of America]

Inspection End Date: October 26, 2023

FEI: 3011195316

Location: BURR RIDGE, IL, United States of America

Investigators: Natasha R Johnson

LifeSouth Community Blood Centers [Palatka / United States of America]

Inspection End Date: October 26, 2023

FEI: 1000143703

Location: PALATKA, FL, United States of America

Investigators: Barbara T Carmichael

Morgan Gallacher [Santa Fe Springs California / United States of America]

Inspection End Date: October 26, 2023

FEI: 2022194

Location: SANTA FE SPRINGS CALIFORNIA, CA, United States of America

Investigators: Darren S Brown, Anney Lin

Fidelitone Order Fulfillment, LLC [Lebanon / United States of America]

Inspection End Date: October 26, 2023

FEI: 3019513796

Location: LEBANON, TENNESSEE TN, United States of America

Investigators: Clinton J Lott

James Melvin Rajan, M.D. [Canton / United States of America]

Inspection End Date: October 26, 2023

FEI: 3027352816

Location: CANTON, OH, United States of America

Investigators: Craig T Rybus

DuPont Nutrition USA, Inc [Newark / United States of America]

Inspection End Date: October 25, 2023

FEI: 3013947845

Location: NEWARK, DE, United States of America

Investigators: Suchan Kim, Yaharn Su, James R Birkenstamm

American National Red Cross [Rock Hill / United States of America]

Inspection End Date: October 24, 2023

FEI: 3021190054

Location: ROCK HILL, SC, United States of America

Investigators: Amy A Johnson

EXCITE PHARMA SERVICES, LLC [Lees Summit / United States of America]

Inspection End Date: October 24, 2023

FEI: 3018068257

Location: LEES SUMMIT, MO, United States of America

Investigators: Torrey M Ward

Artesanales P.R. LLC [Bayamon / United States of America]

Inspection End Date: October 23, 2023

FEI: 3017125056

Location: BAYAMON, PR, United States of America

Investigators: Angelica M Hernandez

SCA Pharmaceuticals [Windsor / United States of America]

Inspection End Date: October 20, 2023

FEI: 3013736415

Location: WINDSOR, CT, United States of America

Investigators: John P Mistler, Jonah S Ufferfilge

KILITCH HEALTHCARE INDIA LIMITED [India / India]

Inspection End Date: October 20, 2023

FEI: 3011853060

Location: INDIA, MAHARASHTRA, India

Investigators: Anastasia M Shields, Justin A Boyd

TZ Medical, Inc. [Tualatin / United States of America]

Inspection End Date: October 20, 2023

FEI: 1000127185

Location: TUALATIN, OR, United States of America

Investigators: Marlo Ianm Alintanahin

Seatex, LLC [Texas / United States of America]

Inspection End Date: October 20, 2023

FEI: 3007709579

Location: TEXAS, TX, United States of America

Investigators: Timothy H Vo

OPTIMOTION IMPLANTS LLC [Orlando / United States of America]

Inspection End Date: October 20, 2023

FEI: 3016470314

Location: ORLANDO, FL, United States of America

Investigators: Brandon P Thompson

A.M. Surgical, Inc. [Smithtown / United States of America]

Inspection End Date: October 20, 2023

FEI: 3001617730

Location: SMITHTOWN, NY, United States of America

Investigators: Kwong P Lee

KCAS, LLC [Shawnee Mission / United States of America]

Inspection End Date: October 20, 2023

FEI: 3003119240

Location: SHAWNEE MISSION, KS, United States of America

Investigators: Yiyue Zhang (nmi), PhD

Alkermes, Inc [Wilmington Ohio / United States of America]

Inspection End Date: October 19, 2023

FEI: 1000142940

Location: WILMINGTON OHIO, OH, United States of America

Investigators: Ucheabuchi C Chudi Nwankwor, Uncheabuchi Cchudi Nwankwor

Linde Gas & Equipment Inc [Livingston / United States of America]

Inspection End Date: October 19, 2023

FEI: 3012160128

Location: LIVINGSTON, TN, United States of America

Investigators: Jamie P Webb

NATCO PHARMA LIMITED [- / India]

Inspection End Date: October 18, 2023

FEI: 3004540906

Location: , , India

Investigators: Pratik S Upadhyay, DDC, Saleem A Akhtar

3-D Matrix, Inc. [Newton / United States of America]

Inspection End Date: October 18, 2023

FEI: 3015528146

Location: NEWTON, MA, United States of America

Investigators: Sara M Onyango

INDOCO REMEDIES LIMITED [India / India]

Inspection End Date: October 18, 2023

FEI: 3006644152

Location: INDIA, , India

Investigators: Kellia N Hicks

Expackusa, Inc. [Jersey / United States of America]

Inspection End Date: October 18, 2023

FEI: 3011064462

Location: JERSEY, NJ, United States of America

Investigators: Suchan Kim, Stephenie M Ortiz, Helen Verdel, Stephanie M Ortiz

Links Medical Products Inc [Laguna Hills / United States of America]

Inspection End Date: October 18, 2023

FEI: 3002995416

Location: LAGUNA HILLS, CA, United States of America

Investigators: Kevin N Tran

Surgical Appliance Industries Inc [Cincinnati / United States of America]

Inspection End Date: October 18, 2023

FEI: 1511629

Location: CINCINNATI, OH, United States of America

Investigators: Teresa K Kastner

Biogen U.S. Corporation [Research Triangle Park / United States of America]

Inspection End Date: October 17, 2023

FEI: 3010164829

Location: RESEARCH TRIANGLE PARK, NORTH CAROLINA NC, United States of America

Investigators: Gene D Arcy, Latorie S Jones

Bing Innovations Llc [Boca Raton / United States of America]

Inspection End Date: October 17, 2023

FEI: 3008500974

Location: BOCA RATON, FL, United States of America

Investigators: David M Wilkinson

Cconma, Inc. [Cerritos / United States of America]

Inspection End Date: October 17, 2023

FEI: 3007919774

Location: CERRITOS, CA, United States of America

Investigators: Sorana Black

American Red Cross Blood Svcs [Durham / United States of America]

Inspection End Date: October 16, 2023

FEI: 1075944

Location: DURHAM, NC, United States of America

Investigators: Steven D Banks, Marla A Cassidy

Ultrum Labs, LLC [Tampa / United States of America]

Inspection End Date: October 16, 2023

FEI: 3017953600

Location: TAMPA, FL, United States of America

Investigators: Damaris Y Hernandez, Nicole E Knowlton

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

Inspection End Date: October 13, 2023

FEI: 3001833549

Location: YORK, NY, United States of America

Investigators: Mindy M Chou, Jazmine N Brown

Jost Chemical Co. [St. Louis / United States of America]

Inspection End Date: October 13, 2023

FEI: 3001239108

Location: ST. LOUIS, MO, United States of America

Investigators: Robert J Ham

Eminent Spine, LLC [Plano / United States of America]

Inspection End Date: October 13, 2023

FEI: 3007345964

Location: PLANO, TX, United States of America

Investigators: Jacey Roy

Newark Beth Israel Medical Center - Blood Bank [Newark / United States of America]

Inspection End Date: October 13, 2023

FEI: 2270850

Location: NEWARK, NJ, United States of America

Investigators: Amy W Yan Mai

Post Oak Innovations, Inc. [Dallas / United States of America]

Inspection End Date: October 13, 2023

FEI: 3009770819

Location: DALLAS, TX, United States of America

Investigators: Katlin N Stubbs

PANACEA BIOTEC PHARMA LIMITED [India / India]

Inspection End Date: October 12, 2023

FEI: 3007187282

Location: INDIA, HIMACHAL PRADESH, India

Investigators: Sandra A Boyd, Muna Algharibeh

Cirtronics Corporation [Milford / United States of America]

Inspection End Date: October 12, 2023

FEI: 3009649442

Location: MILFORD, NH, United States of America

Investigators: James P Finn

DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Hennrietta [Rochester / United States of America]

Inspection End Date: October 12, 2023

FEI: 1315756

Location: ROCHESTER, NY, United States of America

Investigators: Matthew D Schnittker

Medical-technical Gases, Inc. [North Billerica Massachusetts / United States of America]

Inspection End Date: October 12, 2023

FEI: 1215362

Location: NORTH BILLERICA MASSACHUSETTS, MA, United States of America

Investigators: Jonathan G Matrisciano

Kwabena Ntoso M.D [Philadelphia / United States of America]

Inspection End Date: October 11, 2023

FEI: 3011885154

Location: PHILADELPHIA, PA, United States of America

Investigators: Anastasia I Onuorah

Davryan Laboratories, Inc. [Porter / United States of America]

Inspection End Date: October 11, 2023

FEI: 1000523895

Location: PORTER, IN, United States of America

Investigators: Suyang Qin

American Medical Endoscopy, Inc. [Doral / United States of America]

Inspection End Date: October 11, 2023

FEI: 3004361445

Location: DORAL, FL, United States of America

Investigators: Ronald Ifraimov

Stoll Metalcraft Inc [Valencia / United States of America]

Inspection End Date: October 11, 2023

FEI: 3001551180

Location: VALENCIA, CA, United States of America

Investigators: Kelvin Cheung

National Institutes of Health IRB [Bethesda / United States of America]

Inspection End Date: October 11, 2023

FEI: 3013783438

Location: BETHESDA, MD, United States of America

Investigators: Brittany L Carpenter

Nelson Enviromental Technologies, Inc. [Arlington / United States of America]

Inspection End Date: October 10, 2023

FEI: 3010867648

Location: ARLINGTON, TX, United States of America

Investigators: Olalere D Fasipe

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

Inspection End Date: October 6, 2023

FEI: 1819470

Location: INDIANAPOLIS, IN, United States of America

Investigators: Wayne E Seifert, Qiao Y Bobo

Abraxis BioScience, LLC [Phoenix Arizona / United States of America]

Inspection End Date: October 6, 2023

FEI: 3006441852

Location: PHOENIX ARIZONA, AZ, United States of America

Investigators: Nicholas L Hunt, Carrie A Hughes

Steven H. Dayan, MD [Chicago / United States of America]

Inspection End Date: October 6, 2023

FEI: 3008692411

Location: CHICAGO, IL, United States of America

Investigators: Chelsea W Lamm

Afton Scientific, LLC [Charlottesville Virginia / United States of America]

Inspection End Date: October 6, 2023

FEI: 1000123236

Location: CHARLOTTESVILLE VIRGINIA, VA, United States of America

Investigators: Thomas R Withers, Jogy George, Cody D Rickman

Utah Valley Hospital [Provo / United States of America]

Inspection End Date: October 6, 2023

FEI: 3011688420

Location: PROVO, UT, United States of America

Investigators: Emily B Camire

Purdue Pharma L.P. [Stamford / United States of America]

Inspection End Date: October 5, 2023

FEI: 3004365793

Location: STAMFORD, CT, United States of America

Investigators: Tyanna N Hadley

Melvin Zimmerman [New Enterprise / United States of America]

Inspection End Date: October 5, 2023

FEI: 3027997238

Location: NEW ENTERPRISE, PA, United States of America

Investigators: William C Brenneman

Examinetics Inc [Overland Park / United States of America]

Inspection End Date: October 5, 2023

FEI: 3020796592

Location: OVERLAND PARK, KS, United States of America

Investigators: Eric C Fox

Sol-ti Inc. [San Diego / United States of America]

Inspection End Date: October 5, 2023

FEI: 3013414473

Location: SAN DIEGO, CA, United States of America

Investigators: Yen Tso Kuo, Yen Ts Kuo

STAQ Pharma of Ohio, LLC [Columbus / United States of America]

Inspection End Date: October 4, 2023

FEI: 3025336457

Location: COLUMBUS, OH, United States of America

Investigators: Andrew J Barrowcliff

Synovo Production, Inc. [Fullerton / United States of America]

Inspection End Date: October 2, 2023

FEI: 3022090924

Location: FULLERTON, CA, United States of America

Investigators: Kevin N Tran

B & J Group [Morrisville / United States of America]

Inspection End Date: October 2, 2023

FEI: 3010096700

Location: MORRISVILLE, PENNSYLVANIA PA, United States of America

Investigators: Michael L Casner

Xellia Pharmaceuticals USA LLC [Bedford Ohio / United States of America]

Inspection End Date: September 29, 2023

FEI: 3012279857

Location: BEDFORD OHIO, OH, United States of America

Investigators: Alan M Barker, Nicholas J Presto

Clinical Resolution Laboratory, Inc. [California / United States of America]

Inspection End Date: September 29, 2023

FEI: 3005727243

Location: CALIFORNIA, CA, United States of America

Investigators: Bryan A Galvez

Elite BioFusion LLC [Anaheim / United States of America]

Inspection End Date: September 29, 2023

FEI: 3016690702

Location: ANAHEIM, CA, United States of America

Investigators: Eric Zhu, Creighton T Tuzon

Teva Pharmaceuticals USA, Inc [Parsippany / United States of America]

Inspection End Date: September 29, 2023

FEI: 3003092769

Location: PARSIPPANY, NJ, United States of America

Investigators: Mayar M Mussa, Ashley J Burns, Michael Serrano

RR Donnelley - Supply Chain Solutions [Plover / United States of America]

Inspection End Date: September 29, 2023

FEI: 3006371704

Location: PLOVER, WI, United States of America

Investigators: Jesse A Vazquez

CareFusion 213 LLC [El Paso / United States of America]

Inspection End Date: September 29, 2023

FEI: 3004932373

Location: EL PASO, TX, United States of America

Investigators: Oluwasefunm Agbanigo, Rodney L Tinzie, Margaret M Annes

Lonza Tampa LLC [Tampa / United States of America]

Inspection End Date: September 29, 2023

FEI: 3001549109

Location: TAMPA, FL, United States of America

Investigators: Kayla V Sprague, Megan T Ziegler, Suzanne N Vallez

INCELL Corporation LLC [San Antonio / United States of America]

Inspection End Date: September 29, 2023

FEI: 3004107906

Location: SAN ANTONIO, TX, United States of America

Investigators: Richard T Riggie, Bobbi J Miller

EMSL Analytical, Inc. [Jersey / United States of America]

Inspection End Date: September 29, 2023

FEI: 3003933331

Location: JERSEY, NJ, United States of America

Investigators: Kristina L Conroy

Zoetis LLC [Lincoln / United States of America]

Inspection End Date: September 29, 2023

FEI: 1910179

Location: LINCOLN, NEBRASKA NE, United States of America

Investigators: Joohi Castelvetere, Robert J Ham

DCI Donor Services dba Tennessee Donor Services [Nashville / United States of America]

Inspection End Date: September 29, 2023

FEI: 3004125624

Location: NASHVILLE, TN, United States of America

Investigators: Christopher J Adams

Baptist Health IRB #1 [Montgomery / United States of America]

Inspection End Date: September 28, 2023

FEI: 3013791377

Location: MONTGOMERY, AL, United States of America

Investigators: Kellie R Riggs

Prime Line Distributors, Inc. [Fort Lauderdale / United States of America]

Inspection End Date: September 28, 2023

FEI: 3004309676

Location: FORT LAUDERDALE, FL, United States of America

Investigators: Karl D Hezel

SM Rendering, Inc. [Utica / United States of America]

Inspection End Date: September 28, 2023

FEI: 3001451582

Location: UTICA, NY, United States of America

Investigators: Kenneth G Klobus

Siegfried USA, LLC [Pennsville / United States of America]

Inspection End Date: September 27, 2023

FEI: 2227314

Location: PENNSVILLE, NEW JERSEY NJ, United States of America

Investigators: Puspa Suresh Jayasekara, Pushpa S Jayasekara

Germaine Laboratories, Inc [San Antonio / United States of America]

Inspection End Date: September 27, 2023

FEI: 3001451797

Location: SAN ANTONIO, TX, United States of America

Investigators: Jocelyn C Turner

Lyophilization Services Of New England, Inc. (LSNE) [Bedford / United States of America]

Inspection End Date: September 27, 2023

FEI: 3008546445

Location: BEDFORD, NEW HAMPSHIRE NH, United States of America

Investigators: Sean R Marcsisin, Samuel J Arsenault, Lane V Christensen, PhD, Erik W Koester

Piramal Critical Care Inc [Bethlehem / United States of America]

Inspection End Date: September 27, 2023

FEI: 1000135935

Location: BETHLEHEM, PENNSYLVANIA PA, United States of America

Investigators: Amy N Chen

Michelson Laboratories, Inc. [California / United States of America]

Inspection End Date: September 26, 2023

FEI: 2023045

Location: CALIFORNIA, CA, United States of America

Investigators: Tiara M Brown

Exactech, Inc. [Gainesville / United States of America]

Inspection End Date: September 26, 2023

FEI: 1038671

Location: GAINESVILLE, FL, United States of America

Investigators: Karen M Cruz Arenas, Karen M Rodriguez

Robin Industries Healthcare Division [Berlin / United States of America]

Inspection End Date: September 26, 2023

FEI: 3011672474

Location: BERLIN, OH, United States of America

Investigators: Rosanna M Goodrich

Ortho Solutions LC, dba DynaFlex [Lake Saint Louis / United States of America]

Inspection End Date: September 25, 2023

FEI: 1937100

Location: LAKE SAINT LOUIS, MO, United States of America

Investigators: Edward E Lockwood (EEL)

Elutia Inc. [Richmond / United States of America]

Inspection End Date: September 25, 2023

FEI: 1000100754

Location: RICHMOND, CA, United States of America

Investigators: Shelley H Beausoleil, Richard L Bartlett, Tania Y Hall

Abamex Distributors [Chula Vista / United States of America]

Inspection End Date: September 25, 2023

FEI: 3009926929

Location: CHULA VISTA, CA, United States of America

Investigators: Sabino S Camacho

Hitachi Chemical Advanced Therapeutics Solutions, LLC [Allendale / United States of America]

Inspection End Date: September 25, 2023

FEI: 3003407523

Location: ALLENDALE, NJ, United States of America

Investigators: Christine A Harman, PhD, Graeme Price, Phillip C Thai, Graeme E Price, Alan G Baer, Phillip Thai, Alan Baer

Dr. Bruce G. Rankin, DO [Deland / United States of America]

Inspection End Date: September 22, 2023

FEI: 3006528394

Location: DELAND, FL, United States of America

Investigators: Emily S Baldwin, Emily A Baldwin

Nitto Avecia Pharma Services, Inc. [Irvine / United States of America]

Inspection End Date: September 22, 2023

FEI: 3012971227

Location: IRVINE, CALIFORNIA, United States of America

Investigators: Wenzheng Zhang, Wenzheng Wendy Zhang, Carrie A Hughes

Somavac Medical Solutions Inc. [Bartlett / United States of America]

Inspection End Date: September 22, 2023

FEI: 3014827316

Location: BARTLETT, TN, United States of America

Investigators: Nikki S Bryant

Ionetix Corporation [Knoxville / United States of America]

Inspection End Date: September 22, 2023

FEI: 3025767691

Location: KNOXVILLE, TENNESSEE TN, United States of America

Investigators: Gretchen M Laws, Joanne E King

Atlas Medical Holdings Inc [San Antonio / United States of America]

Inspection End Date: September 21, 2023

FEI: 3020833827

Location: SAN ANTONIO, TX, United States of America

Investigators: Robert M Tillman, Bobbi J Miller

Curia New Jersey, LLC [Lebanon / United States of America]

Inspection End Date: September 21, 2023

FEI: 3003822883

Location: LEBANON, NEW JERSEY NJ, United States of America

Investigators: Janet A Rajan

International Trading Pharm Lab Inc [Paterson / United States of America]

Inspection End Date: September 21, 2023

FEI: 1000208853

Location: PATERSON, NJ, United States of America

Investigators: Jessica S Estriplet, Yoriann Mcabrera Bartolomei, Stephenie M Ortiz

Re-Gen Active Lab Inc [Irving / United States of America]

Inspection End Date: September 21, 2023

FEI: 3015174203

Location: IRVING, TX, United States of America

Investigators: Emily S Mcgann, William F Lagud, Jr

Higley Industries, Inc. [Dyersville / United States of America]

Inspection End Date: September 21, 2023

FEI: 3002984417

Location: DYERSVILLE, IA, United States of America

Investigators: Torrey M Ward

ModernaTX, Inc. [Norwood / United States of America]

Inspection End Date: September 21, 2023

FEI: 3014937058

Location: NORWOOD, MASSACHUSETTS, United States of America

Investigators: Unnee Ranjan, Ben Firschein, Ben A Firschein, Swati Verma, Thai D Truong

Orange Lab [Anaheim / United States of America]

Inspection End Date: September 21, 2023

FEI: 3011893701

Location: ANAHEIM, CALIFORNIA, United States of America

Investigators: Andrew Le, Darren S Brown

Colgin Inc [Dallas / United States of America]

Inspection End Date: September 21, 2023

FEI: 1610391

Location: DALLAS, TX, United States of America

Investigators: Alan A Rivera

Quicksilver Scientific [Louisville / United States of America]

Inspection End Date: September 21, 2023

FEI: 3006664651

Location: LOUISVILLE, CO, United States of America

Investigators: Katlin N Stubbs, Jennifer A Robinson

Bridge to Life Ltd [Northbrook / United States of America]

Inspection End Date: September 21, 2023

FEI: 3015942785

Location: NORTHBROOK, IL, United States of America

Investigators: Nydia E Colon

One Response

Leave a Reply