Recently Published FDA Form 483s

Apitoria Pharma Private Limited [Patancheru / India]

Inspection End Date: September 27, 2024

FEI: 3004086884

Location: PATANCHERU, TELANGANA, India

BIOCON SDN.BHD. [Iskandar Puteri / Malaysia]

Inspection End Date: September 27, 2024

FEI: 3011248248

Location: ISKANDAR PUTERI, JOHOR, Malaysia

Nephron Sterile Compounding Center, LLC [West Columbia / United States of America]

Inspection End Date: September 25, 2024

FEI: 3011158388

Location: WEST COLUMBIA, SOUTH CAROLINA, United States of America

Aarti Drugs Limited [Tarapur / India]

Inspection End Date: September 20, 2024

FEI: 3006418686

Location: TARAPUR, MAHARASHTRA, India

Arrow Reliance Inc [Tukwila / United States of America]

Inspection End Date: September 18, 2024

FEI: 3007652252

Location: TUKWILA, WASHINGTON, United States of America

Investigators: Jeannine K Wooten, Kenneth G Klobus, Julia Ventura

WalkMed, LLC [Aurora / United States of America]

Inspection End Date: September 13, 2024

FEI: 3000204189

Location: AURORA, COLORADO, United States of America

Investigators: Nga T Ho, Matthew M Vernon

Emerald Kalama Chemical, LLC [Kalama / United States of America]

Inspection End Date: September 12, 2024

FEI: 3022820

Location: KALAMA, WASHINGTON, United States of America

Investigators: Nathan E Hellman, Kham Phommachanh

Karl Storz Endoscopy [El Segundo / United States of America]

Inspection End Date: September 12, 2024

FEI: 3007475226

Location: EL SEGUNDO, CALIFORNIA, United States of America

Investigators: Shannon A Gregory

ADAMSON ANALYTICAL LABORATORIES INC [Corona / United States of America]

Inspection End Date: September 12, 2024

FEI: 3000204955

Location: CORONA, CALIFORNIA, United States of America

Investigators: Darren S Brown, Ngozi G Offor

Medical Purchasing Solutions, LLC [Scottsdale / United States of America]

Inspection End Date: September 11, 2024

FEI: 3014288534

Location: SCOTTSDALE, ARIZONA, United States of America

Investigators: Christopher M Jenner

David Weisman, M.D. [Abington / United States of America]

Inspection End Date: September 9, 2024

FEI: 3031508738

Location: ABINGTON, PENNSYLVANIA, United States of America

Investigators: Stephanie Mangigian, MS/OSH, RN

Mark Cuban Cost Plus Manufacturing and Compounding LLC [Dallas / United States of America]

Inspection End Date: September 6, 2024

FEI: 3024611767

Location: DALLAS, TEXAS, United States of America

Jeffrey M. Steinberg MD, Inc., a Professional Medical Corporation dba The Fertility Institutes [Encino / United States of America]

Inspection End Date: September 6, 2024

FEI: 3003942486

Location: ENCINO, CALIFORNIA, United States of America

Investigators: Creighton T Tuzon

Alkaline Corporation [Eatontown / United States of America]

Inspection End Date: September 6, 2024

FEI: 1000526882

Location: EATONTOWN, NEW JERSEY, United States of America

Investigators: Frederick F Razzaghi

Caridian BCT Sterlization [Lakewood / United States of America]

Inspection End Date: September 5, 2024

FEI: 3003094851

Location: LAKEWOOD, COLORADO, United States of America

Investigators: Christine I Shaw

Validation Systems, Inc. [Palo Alto / United States of America]

Inspection End Date: September 5, 2024

FEI: 3006717832

Location: PALO ALTO, CALIFORNIA, United States of America

Investigators: Anney Lin, Khoa Nathanv Tran

Cade Medical, Inc. [Temecula / United States of America]

Inspection End Date: August 30, 2024

FEI: 3011724860

Location: TEMECULA, CALIFORNIA, United States of America

Investigators: Eric Zhu

Circadiance LLC [Turtle Creek / United States of America]

Inspection End Date: August 30, 2024

FEI: 3006182632

Location: TURTLE CREEK, PENNSYLVANIA, United States of America

Investigators: Dennis R Hock

Alcon Research, LLC [Fort Worth / United States of America]

Inspection End Date: August 30, 2024

FEI: 1610287

Location: FORT WORTH, TEXAS, United States of America

Investigators: Kevin T Nguyen, Shanna N Purdy, Clinton J Lott, Margaret M Annes

Dextrum Laboratories Inc. [Miami / United States of America]

Inspection End Date: August 29, 2024

FEI: 3003092372

Location: MIAMI, FLORIDA, United States of America

Investigators: Jennifer Lalama, J'maica J Hunter

Syfrett Feed Company, Inc. [Okeechobee / United States of America]

Inspection End Date: August 28, 2024

FEI: 1000028052

Location: OKEECHOBEE, FLORIDA, United States of America

Investigators: Stacey L Witherwax, Alec D Fabus

Empower Clinic Services LLC dba Empower Pharmacy [Houston / United States of America]

Inspection End Date: August 28, 2024

FEI: 3011887629

Location: HOUSTON, TEXAS, United States of America

Investigators: Dogbeda F Mackenzie, Taichun Qin, PhD

Alexander Khoruts, M.D., Sponsor-Investigator [Minneapolis / United States of America]

Inspection End Date: August 26, 2024

FEI: 3031081630

Location: MINNEAPOLIS, MINNESOTA, United States of America

Investigators: Sharon L Matson

Supreme Orthopedic Systems Inc [Marriottsville / United States of America]

Inspection End Date: August 23, 2024

FEI: 3009190212

Location: MARRIOTTSVILLE, MARYLAND, United States of America

Investigators: Richard J Bashay

Shirish M. Gadgeel, MD [Detroit / United States of America]

Inspection End Date: August 23, 2024

FEI: 3011706278

Location: DETROIT, MICHIGAN, United States of America

Investigators: Dina A Tallman

Merck Sharp & Dohme LLC [Lansdale / United States of America]

Inspection End Date: August 23, 2024

FEI: 2510592

Location: LANSDALE, PENNSYLVANIA, United States of America

Investigators: Unnee Ranjan, Olga Simakova, PhD, Travis S Bradley

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

Inspection End Date: August 23, 2024

FEI: 3005550748

Location: NASHVILLE, TENNESSEE, United States of America

Investigators: Jared P Stevens

Percussionaire Corporation [Sandpoint / United States of America]

Inspection End Date: August 22, 2024

FEI: 1000524541

Location: SANDPOINT, IDAHO, United States of America

Investigators: Clifford F Long

Sanober Kable, M.D. [Denison / United States of America]

Inspection End Date: August 21, 2024

FEI: 3031371247

Location: DENISON, TEXAS, United States of America

Investigators: Joanne M Schlossin

Bioaccess, Inc. [Baltimore / United States of America]

Inspection End Date: August 20, 2024

FEI: 1000513050

Location: BALTIMORE, MARYLAND, United States of America

Investigators: Nisha C Patel

Pacific Reproductive Center, Inc. [Irvine / United States of America]

Inspection End Date: August 19, 2024

FEI: 3005861788

Location: IRVINE, CALIFORNIA, United States of America

Investigators: Melsomar R Ramos

Gustavo Fonseca, M.D. [Lecanto / United States of America]

Inspection End Date: August 16, 2024

FEI: 3030827717

Location: LECANTO, FLORIDA, United States of America

Investigators: Emily C Caldwell

Priority Pet Products [Pawtucket / United States of America]

Inspection End Date: August 15, 2024

FEI: 3005593562

Location: PAWTUCKET, RHODE ISLAND, United States of America

Investigators: Stephanie M Roberts Pedotti

Caldic USA Inc [University Park / United States of America]

Inspection End Date: August 15, 2024

FEI: 1450491

Location: UNIVERSITY PARK, ILLINOIS, United States of America

Investigators: Muna Algharibeh

MIDI Labs, Inc. [Newark / United States of America]

Inspection End Date: August 15, 2024

FEI: 3005786028

Location: NEWARK, DELAWARE, United States of America

Investigators: Tekalign Wondimu, Young K Chou, Lu Chen, Kara J Wright

Stratus Pharmaceuticals Inc [Miami / United States of America]

Inspection End Date: August 15, 2024

FEI: 3002787468

Location: MIAMI, FLORIDA, United States of America

Investigators: Saundrea A Munroe

AIRGAS USA, LLC [Houston / United States of America]

Inspection End Date: August 15, 2024

FEI: 1619686

Location: HOUSTON, TEXAS, United States of America

Investigators: Timothy H Vo

Maimonides Medical Center [Brooklyn / United States of America]

Inspection End Date: August 15, 2024

FEI: 2473845

Location: BROOKLYN, NEW YORK, United States of America

Investigators: Amy Wyan Mai, Amy Kim

Vitrologic, Inc., dba Specialty Blood Center [Charleston / United States of America]

Inspection End Date: August 14, 2024

FEI: 3006384472

Location: CHARLESTON, SOUTH CAROLINA, United States of America

Investigators: Kenneth L Smalls, Chanel E Crawford

Microbiome Health Research Institute (dba OpenBiome) [Woburn / United States of America]

Inspection End Date: August 14, 2024

FEI: 3015197036

Location: WOBURN, MASSACHUSETTS, United States of America

Investigators: Jose A Torres

Specialists in Reproductive Medicine & Surgery, P.A. [Fort Myers / United States of America]

Inspection End Date: August 14, 2024

FEI: 3003926777

Location: FORT MYERS, FLORIDA, United States of America

Investigators: Lizaida Perez, Ivan E Reyes

OAKWOOD LABORATORIES, L.L.C. [Solon / United States of America]

Inspection End Date: August 13, 2024

FEI: 3003693370

Location: SOLON, OHIO, United States of America

Investigators: Paranthaman Senthamaraikannan

Emily DiMango, M.D. [New York / United States of America]

Inspection End Date: August 13, 2024

FEI: 3013753808

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

Investigators: Omadevi Somai, Investigator

Folsom Metal Products, Inc. [Pelham / United States of America]

Inspection End Date: August 9, 2024

FEI: 3006803588

Location: PELHAM, ALABAMA, United States of America

Investigators: Jamie P Webb

Shasta Eye Medical Group, Inc. [Redding / United States of America]

Inspection End Date: August 9, 2024

FEI: 3007902181

Location: REDDING, CALIFORNIA, United States of America

Investigators: Joan T Briones, Cynthia J Tsui

Q'apel Medical, Inc. [Fremont / United States of America]

Inspection End Date: August 8, 2024

FEI: 3020954126

Location: FREMONT, CALIFORNIA, United States of America

Investigators: Mary A Millner, Jocelyn C Turner

Novartis Pharmaceuticals Corporation [Morris Plains / United States of America]

Inspection End Date: August 8, 2024

FEI: 3010353512

Location: MORRIS PLAINS, NEW JERSEY, United States of America

Investigators: Unnee Ranjan, Laurel A Beer

Tenco Assemblies, Inc. [Morrisville / United States of America]

Inspection End Date: August 7, 2024

FEI: 3001452536

Location: MORRISVILLE, PENNSYLVANIA, United States of America

Investigators: Ruben C Quintana

Carolinas Medical Center [Charlotte / United States of America]

Inspection End Date: August 7, 2024

FEI: 1072484

Location: CHARLOTTE, NORTH CAROLINA, United States of America

Investigators: Randy L Clarida

Global Calcium Private Limited [Hosur / India]

Inspection End Date: August 2, 2024

FEI: 3004094136

Location: HOSUR, TAMIL NADU, India

Investigators: Justin A Boyd, Teresa I Navas

TROYA DEL CAMPO USA LLC [Mcallen / United States of America]

Inspection End Date: August 2, 2024

FEI: 3017920783

Location: MCALLEN, TEXAS, United States of America

Investigators: Samuel S Cuevas

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

Inspection End Date: August 2, 2024

FEI: 1000124207

Location: MORGAN HILL, CALIFORNIA, United States of America

Investigators: Marlo Ianm Alintanahin

Sanofi Pasteur Inc. [Swiftwater / United States of America]

Inspection End Date: August 2, 2024

FEI: 2518760

Location: SWIFTWATER, PENNSYLVANIA, United States of America

Investigators: Scott T Ballard, Shafiq S Ahadi

ProRx LLC [Exton / United States of America]

Inspection End Date: August 2, 2024

FEI: 3022250654

Location: EXTON, PENNSYLVANIA, United States of America

Investigators: Karishma G Gopaul, Jazmine N Brown

Micra Biotechnologies Inc [River Edge / United States of America]

Inspection End Date: August 2, 2024

FEI: 1000122226

Location: RIVER EDGE, NEW JERSEY, United States of America

Investigators: Juanita P Versace

Clarus Safety Consulting, LLC [Schererville / United States of America]

Inspection End Date: August 2, 2024

FEI: 3030055940

Location: SCHERERVILLE, INDIANA, United States of America

Investigators: Colleen E Burke

Baxter Healthcare Corporation [Round Lake / United States of America]

Inspection End Date: August 1, 2024

FEI: 1416980

Location: ROUND LAKE, ILLINOIS, United States of America

Investigators: Monica E Murie, Lisa L Flores, Chad W Rice

Furst-McNess Company [Lodi / United States of America]

Inspection End Date: August 1, 2024

FEI: 3003426240

Location: LODI, WISCONSIN, United States of America

Investigators: Tyson J Eldridge Stedman

Strukmyer Medical [Mesquite / United States of America]

Inspection End Date: August 1, 2024

FEI: 3000205837

Location: MESQUITE, TEXAS, United States of America

Investigators: Hala L Selby, Oluwasefunmi Agbanigo

iRhythm Technologies Inc [San Francisco / United States of America]

Inspection End Date: July 31, 2024

FEI: 3007208829

Location: SAN FRANCISCO, CALIFORNIA, United States of America

Investigators: Kenya Destin, Katelyn Astaub Zamperini

iRhythm Technologies, Inc. [Cypress / United States of America]

Inspection End Date: July 31, 2024

FEI: 3021769057

Location: CYPRESS, CALIFORNIA, United States of America

Investigators: Katlin N Stubbs, James R Montero

ADVANCED AMBULATORY, INC [Houston / United States of America]

Inspection End Date: July 31, 2024

FEI: 3015004731

Location: HOUSTON, TEXAS, United States of America

Investigators: Ellen J Tave

AIRGAS USA, LLC [Rochester / United States of America]

Inspection End Date: July 31, 2024

FEI: 1314605

Location: ROCHESTER, NEW YORK, United States of America

Investigators: Vivin George

Samsung Biologics Co., Ltd. [Incheon / Korea (Republic of)]

Inspection End Date: July 30, 2024

FEI: 3010479596

Location: INCHEON, INCHEON, Korea (Republic of)

Investigators: Zhong Li, PhD, Yiwei Li, Andrea Franco, Xuhong Li, Charles Kuo, PhD, Jacek Cieslok, PhD

ACCU BIO-CHEM LABS [Glendale / United States of America]

Inspection End Date: July 30, 2024

FEI: 3004876794

Location: GLENDALE, CALIFORNIA, United States of America

Investigators: Youkeun Kim, Gunneet Kaur

Alicia Cabrera, M.D. [Altamonte Springs / United States of America]

Inspection End Date: July 30, 2024

FEI: 3031118763

Location: ALTAMONTE SPRINGS, FLORIDA, United States of America

Investigators: Emily C Caldwell, Sheri L Stephenson

Denison Pharmaceuticals, LLC [Lincoln / United States of America]

Inspection End Date: July 29, 2024

FEI: 1210580

Location: LINCOLN, RHODE ISLAND, United States of America

Investigators: Ifechimere I Okafor, Lori M Newman, Daniel L Zheng

Curewave Lasers LLC [Dallas / United States of America]

Inspection End Date: July 29, 2024

FEI: 3014268427

Location: DALLAS, TEXAS, United States of America

Investigators: Matthew M Vernon