Recently Published FDA Form 483s

Charles River Laboratories, Inc. [Wilmington / United States of America]

Inspection End Date: September 9, 2025

FEI: 1000086712

Location: WILMINGTON, MASSACHUSETTS, United States of America

Investigators: Erik W Koester

Issam Makhoul [Little Rock / United States of America]

Inspection End Date: September 8, 2025

FEI: 3038882450

Location: LITTLE ROCK, ARKANSAS, United States of America

Investigators: Terri E Gibson

Aurobindo Pharma Limited [Hyderabad / India]

Inspection End Date: September 5, 2025

FEI: 3004446312

Location: HYDERABAD, TELANGANA, India

Investigators: Joseph A Piechocki, Eileen A Liu, Claudia Mperez Kasmarski

Dr. Reddy's Laboratories (EU) Ltd. [Mirfield / United Kingdom of Great Britain and Northern Ireland]

Inspection End Date: September 5, 2025

FEI: 3002807544

Location: MIRFIELD, ENGLAND, United Kingdom of Great Britain and Northern Ireland

Investigators: Arsen Karapetyan, Yoriann M Cabrera Bartolomei

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

Inspection End Date: September 5, 2025

FEI: 3008488707

Location: OVERLAND PARK, KANSAS, United States of America

Investigators: Andrew Le

LUPIN LIMITED [Aurangabad / India]

Inspection End Date: September 5, 2025

FEI: 3004995645

Location: AURANGABAD, MAHARASHTRA, India

Investigators: Christopher R Czajka

Zydus Lifesciences Limited [Waghodia / India]

Inspection End Date: September 5, 2025

FEI: 3013712903

Location: WAGHODIA, GUJARAT, India

Investigators: José E Meléndez, Angelica M Hernandez, Damaris Y Hernandez

International Chemical Entity Japan Co.,Ltd. [Jobammisawamachi / Japan]

Inspection End Date: September 5, 2025

FEI: 3004546088

Location: JOBAMMISAWAMACHI, FUKUSHIMA, Japan

Investigators: Geoffrey K Kilili

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding [Richardson / United States of America]

Inspection End Date: September 5, 2025

FEI: 3014229024

Location: RICHARDSON, TEXAS, United States of America

Investigators: Demario L Walls

Central Admixture Pharmacy Services, Inc. [Phoenix / United States of America]

Inspection End Date: September 5, 2025

FEI: 3014307835

Location: PHOENIX, ARIZONA, United States of America

Investigators: Roger F Zabinski, Homero W Aguilar

FARMAKEIO OUTSOURCING LLC [Southlake / United States of America]

Inspection End Date: September 5, 2025

FEI: 3014982757

Location: SOUTHLAKE, TEXAS, United States of America

Investigators: Camerson E Moore

Central Admixture Pharmacy Services, Inc. [Allentown / United States of America]

Inspection End Date: September 5, 2025

FEI: 3009590582

Location: ALLENTOWN, PENNSYLVANIA, United States of America

Investigators: Luis P Torres, Seneca D Toms

MRIAUDIO, INC. [Carlsbad / United States of America]

Inspection End Date: September 5, 2025

FEI: 3014680716

Location: CARLSBAD, CALIFORNIA, United States of America

Investigators: Jenny L Chisem

Janssen Pharmaceutica NV [Beerse / Belgium]

Inspection End Date: September 5, 2025

FEI: 3002807336

Location: BEERSE, VLAAMS GEWEST, Belgium

Investigators: Xingfang Li, MD, Ruben C Ayala, PharmD

Advin Biotech, Inc. [San Diego / United States of America]

Inspection End Date: September 5, 2025

FEI: 3010934853

Location: SAN DIEGO, CALIFORNIA, United States of America

Investigators: Juanj N Wu

Robert G Perry [Miami / United States of America]

Inspection End Date: September 5, 2025

FEI: 3010352666

Location: MIAMI, FLORIDA, United States of America

Investigators: LT Richard A Lyght

United-Guardian, Inc. [Hauppauge / United States of America]

Inspection End Date: September 4, 2025

FEI: 2410853

Location: HAUPPAUGE, NEW YORK, United States of America

Investigators: Divek R Jumani

Pharmgate Inc. [Omaha / United States of America]

Inspection End Date: September 4, 2025

FEI: 1921641

Location: OMAHA, NEBRASKA, United States of America

Investigators: Supreet K Sran

Qualgen, LLC [Edmond / United States of America]

Inspection End Date: September 4, 2025

FEI: 3011286349

Location: EDMOND, OKLAHOMA, United States of America

Investigators: Logan T Williams, Zachary L Stamm

Sparsha Pharma USA, Inc. [Oceanside / United States of America]

Inspection End Date: September 4, 2025

FEI: 3010888655

Location: OCEANSIDE, CALIFORNIA, United States of America

Investigators: Cecilia H Kieu, Crystal Monroy, Navneet Kaur, Joey V Quitania, Katherine E Jacobitz

Biocon Biologics Limited [Bengaluru / India]

Inspection End Date: September 3, 2025

FEI: 3015283245

Location: BENGALURU, KARNATAKA, India

Investigators: Guerlain Ulysse

SOFIE Co. dba SOFIE [Kansas City / United States of America]

Inspection End Date: September 3, 2025

FEI: 3008310003

Location: KANSAS CITY, MISSOURI, United States of America

Investigators: Andrew Le

Charles River Laboratories Edinburgh Ltd. [Tranent / United Kingdom of Great Britain and Northern Ireland]

Inspection End Date: September 2, 2025

FEI: 1000544053

Location: TRANENT, SCOTLAND, United Kingdom of Great Britain and Northern Ireland

Investigators: Jose M Cayuela

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

Inspection End Date: September 2, 2025

FEI: 3007684134

Location: NORTH WALES, PENNSYLVANIA, United States of America

Investigators: Anastasia M Shields

Kreitchman PET Center [New York / United States of America]

Inspection End Date: September 2, 2025

FEI: 3009498040

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

Investigators: Mindy M Chou, Janet A Rajan

Microconstants Inc [San Diego / United States of America]

Inspection End Date: August 29, 2025

FEI: 3007236564

Location: SAN DIEGO, CALIFORNIA, United States of America

Investigators: Humberto Z Gomez, Scott N Lim

BELOTECA INC [San Diego / United States of America]

Inspection End Date: August 29, 2025

FEI: 3027971087

Location: SAN DIEGO, CALIFORNIA, United States of America

Investigators: Lan T Tran, Linh T Tu

Apitoria Pharma Private Limited [Hathnoora / India]

Inspection End Date: August 29, 2025

FEI: 3004021253

Location: HATHNOORA, TELANGANA, India

Investigators: Pearl C Ozuruigbo, Rajiv Ranjan Srivastava

Minteq U K LTD [Birmingham / United Kingdom of Great Britain and Northern Ireland]

Inspection End Date: August 29, 2025

FEI: 3001854763

Location: BIRMINGHAM, ENGLAND, United Kingdom of Great Britain and Northern Ireland

Investigators: Jose M Cayuela

Midwest Products and Engineering Inc [Milwaukee / United States of America]

Inspection End Date: August 29, 2025

FEI: 3003500271

Location: MILWAUKEE, WISCONSIN, United States of America

Investigators: Chad E Schmear

SGS France [Arcueil / France]

Inspection End Date: August 29, 2025

FEI: 3005865090

Location: ARCUEIL, ÎLE-DE-FRANCE, France

Investigators: Xingfang Li, MD, Ruben C Ayala, PharmD

Bio-Medical Pharmaceutical Manufacturing Corporation [Houston / United States of America]

Inspection End Date: August 29, 2025

FEI: 1650090

Location: HOUSTON, TEXAS, United States of America

Investigators: Ronda Rloyd Jones, Milton J De Jesus Tavarez

Integris Bioservices LLC [Shawnee / United States of America]

Inspection End Date: August 29, 2025

FEI: 3003119240

Location: SHAWNEE, KANSAS, United States of America

Investigators: Courtney R Bratina, Audrey J Yarbrough, Carmen Y Fisher

MEDLINE INDUSTRIES, LP - Northfield [Northfield / United States of America]

Inspection End Date: August 29, 2025

FEI: 1417592

Location: NORTHFIELD, ILLINOIS, United States of America

Investigators: Michelle J Glembin, Edward E Lockwood (EEL)

RC Outsourcing, LLC [Lowellville / United States of America]

Inspection End Date: August 28, 2025

FEI: 3011967886

Location: LOWELLVILLE, OHIO, United States of America

Investigators: Margaret M Annes

RK PHARMA INC [Pearl River / United States of America]

Inspection End Date: August 28, 2025

FEI: 3014926340

Location: PEARL RIVER, NEW YORK, United States of America

Investigators: Lata C Mathew, PhD

GUERBET LLC [Princeton / United States of America]

Inspection End Date: August 28, 2025

FEI: 3014243475

Location: PRINCETON, NEW JERSEY, United States of America

Investigators: David L Chon

EPIEN Medical, Inc. [Saint Paul / United States of America]

Inspection End Date: August 28, 2025

FEI: 3003428492

Location: SAINT PAUL, MINNESOTA, United States of America

Investigators: Anna M Spiros

Cardinal Health 414, LLC [Van Nuys / United States of America]

Inspection End Date: August 28, 2025

FEI: 3003411145

Location: VAN NUYS, CALIFORNIA, United States of America

Investigators: Youkeun Kim, Lillian S Wu, Rowena S Nguyen

SOFIE Co. dba SOFIE [Morgantown / United States of America]

Inspection End Date: August 28, 2025

FEI: 3005705842

Location: MORGANTOWN, WEST VIRGINIA, United States of America

Investigators: David A Oluwo

Mini Melts USA, Inc. [Norwich / United States of America]

Inspection End Date: August 28, 2025

FEI: 3005430399

Location: NORWICH, CONNECTICUT, United States of America

Investigators: Alysia M Salonia, Terry E Pierre

Engineered Endodontics, LLC [Menomonee Falls / United States of America]

Inspection End Date: August 28, 2025

FEI: 3012322979

Location: MENOMONEE FALLS, WISCONSIN, United States of America

Investigators: Shawn Choi

Crescent Marketing, Inc. dba Crescent Mfg [North Collins / United States of America]

Inspection End Date: August 28, 2025

FEI: 3006746263

Location: NORTH COLLINS, NEW YORK, United States of America

Investigators: Lauren H Augustyniak, Jordan S Burkdoll

Beutlich Pharmaceuticals, LLC [Bunnell / United States of America]

Inspection End Date: August 27, 2025

FEI: 1413399

Location: BUNNELL, FLORIDA, United States of America

Investigators: Jose Velez

ten23 health Valais AG [Visp / Switzerland]

Inspection End Date: August 27, 2025

FEI: 3014757826

Location: VISP, VALAIS, Switzerland

Investigators: Sudipan Karmakar, Liqun Zhao

Emergent BioSolutions Canada Inc [Winnipeg / Canada]

Inspection End Date: August 27, 2025

FEI: 3003153579

Location: WINNIPEG, MANITOBA, Canada

Investigators: Laurimer Kuilan Torres

TreyMed, Inc. [Sussex / United States of America]

Inspection End Date: August 27, 2025

FEI: 3003007937

Location: SUSSEX, WISCONSIN, United States of America

Investigators: Shuana H Xiong

Melaleuca [Idaho Falls / United States of America]

Inspection End Date: August 27, 2025

FEI: 3021937

Location: IDAHO FALLS, IDAHO, United States of America

Investigators: Matthew R Clabeaux

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

Inspection End Date: August 27, 2025

FEI: 1038671

Location: GAINESVILLE, FLORIDA, United States of America

Investigators: Mary A Millner, Ronald Ifraimov

Bronco Research Services dba inotiv Fort Collins [Fort Collins / United States of America]

Inspection End Date: August 26, 2025

FEI: 3005560751

Location: FORT COLLINS, COLORADO, United States of America

Investigators: Theressa B Smith

Eurofins Lancaster Laboratories, Inc [Lancaster / United States of America]

Inspection End Date: August 26, 2025

FEI: 2513291

Location: LANCASTER, PENNSYLVANIA, United States of America

Investigators: Junho Pak

Magellan Diagnostics, Inc. [North Billerica / United States of America]

Inspection End Date: August 26, 2025

FEI: 1218996

Location: NORTH BILLERICA, MASSACHUSETTS, United States of America

Investigators: Sunita Pandey

Thermo Fisher Scientific (Asheville) LLC [Marietta / United States of America]

Inspection End Date: August 26, 2025

FEI: 1523845

Location: MARIETTA, OHIO, United States of America

Investigators: Javonica F Penn

American Airlines [Morrisville / United States of America]

Inspection End Date: August 26, 2025

FEI: 1038604

Location: MORRISVILLE, NORTH CAROLINA, United States of America

Investigators: Mokhless A Ghaly

Bajaj Medical, LLC [Chicago / United States of America]

Inspection End Date: August 25, 2025

FEI: 3010164083

Location: CHICAGO, ILLINOIS, United States of America

Investigators: Tyler M Peterson

Varian Medical Systems, Inc., X-ray Products Division [Salt Lake City / United States of America]

Inspection End Date: August 25, 2025

FEI: 1717855

Location: SALT LAKE CITY, UTAH, United States of America

Investigators: James R Montero