Recently Published FDA Form 483s

Lydia Hernandez, M.D. [Cincinnati / United States of America]

Inspection End Date: September 17, 2024

FEI: 3031512345

Location: CINCINNATI, OHIO, United States of America

Investigators: Kathryn Suttling

Rockwell Medical [Grapevine / United States of America]

Inspection End Date: September 16, 2024

FEI: 3003463852

Location: GRAPEVINE, TEXAS, United States of America

Investigators: Katlin N Stubbs, Elizabeth A Krolczyk

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

Pedro A. Velasquez-Mieyer, M.D. [Memphis / United States of America]

Inspection End Date: September 13, 2024

FEI: 3031753125

Location: MEMPHIS, TENNESSEE, United States of America

Investigators: Kellie R Riggs, Abigail M Cruz

Accupac, LLC [Lakewood / United States of America]

Inspection End Date: September 13, 2024

FEI: 3010166945

Location: LAKEWOOD, NEW JERSEY, United States of America

Investigators: Yoriann M Cabrera Bartolomei, Janet A Rajan

Luster Products, Inc. [Chicago / United States of America]

Inspection End Date: September 13, 2024

FEI: 1417123

Location: CHICAGO, ILLINOIS, United States of America

Investigators: Travis V Hull, Wayne D Mcgrath

ABR Laboratory LLC [Hollywood / United States of America]

Inspection End Date: September 13, 2024

FEI: 3020570829

Location: HOLLYWOOD, FLORIDA, United States of America

Investigators: Kayla V Sprague

Nostrum Laboratories, Inc. [Kansas City / United States of America]

Inspection End Date: September 13, 2024

FEI: 1930436

Location: KANSAS CITY, MISSOURI, United States of America

Investigators: Melissa M Steiger, Robert J Ham

Midlab Incorporated [Athens / United States of America]

Inspection End Date: September 13, 2024

FEI: 3001236208

Location: ATHENS, TENNESSEE, United States of America

Investigators: Gretchen M Laws

Kimberly L. Wagner, M.D. [Colorado Springs / United States of America]

Inspection End Date: September 13, 2024

FEI: 3031239663

Location: COLORADO SPRINGS, COLORADO, United States of America

Investigators: Courtney R Bratina

COSMECCA KOREA CO., LTD [Daeso-Myeon / Korea (Republic of)]

Inspection End Date: September 13, 2024

FEI: 3010165567

Location: DAESO-MYEON, CHUNGCHEONGBUK-DO, Korea (Republic of)

Investigators: Jeffrey P Raimondi, Paranthaman Senthamaraikannan

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

University Of Virginia Health System [Charlottesville / United States of America]

Inspection End Date: September 12, 2024

FEI: 1172512

Location: CHARLOTTESVILLE, VIRGINIA, United States of America

Investigators: La Tasham Gunter

Rite-Kem Incorporated [Tupelo / United States of America]

Inspection End Date: September 12, 2024

FEI: 1000337046

Location: TUPELO, MISSISSIPPI, United States of America

Investigators: Demario L Walls

Rebel Converting, LLC [Saukville / United States of America]

Inspection End Date: September 12, 2024

FEI: 3019356454

Location: SAUKVILLE, WISCONSIN, United States of America

Investigators: Christopher D Leach, Gabriel Bermudez Picart

Wasatch Product Development, LLC. [Draper / United States of America]

Inspection End Date: September 12, 2024

FEI: 3003676119

Location: DRAPER, UTAH, United States of America

Investigators: Thuy T Nguyen, LCDR, Andrew Le, Navneet Kaur

Shree Jaya Laboratories Private Limited [Choutuppal / India]

Inspection End Date: September 12, 2024

FEI: 3011845012

Location: CHOUTUPPAL, TELANGANA, India

Investigators: Yvins Dezan, Walden H Lee

Randy D. Hicks, M.D. [Flint / United States of America]

Inspection End Date: September 12, 2024

FEI: 3031511465

Location: FLINT, MICHIGAN, United States of America

Investigators: Dina A Tallman, Victoria R Flournoy

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

Sperm Bank, Inc. dba Fertility Center of California [Tustin / United States of America]

Inspection End Date: September 11, 2024

FEI: 3005210448

Location: TUSTIN, CALIFORNIA, United States of America

Investigators: Creighton T Tuzon

The Procter & Gamble Manufacturing Company [Kansas City / United States of America]

Inspection End Date: September 11, 2024

FEI: 1925189

Location: KANSAS CITY, KANSAS, United States of America

Investigators: David A Oluwo, Tomika L Crafter

Professional Disposables International, Inc. [Orangeburg / United States of America]

Inspection End Date: September 11, 2024

FEI: 2411192

Location: ORANGEBURG, NEW YORK, United States of America

Investigators: Jenny Sung, Jonathan G Matrisciano, Erik W Koester

Noel D. Elmore [Glasgow / United States of America]

Inspection End Date: September 11, 2024

FEI: 3010490215

Location: GLASGOW, KENTUCKY, United States of America

Investigators: Lisa M Marko

Synergy Animal Products, Inc. [Bethel / United States of America]

Inspection End Date: September 10, 2024

FEI: 3000210195

Location: BETHEL, PENNSYLVANIA, United States of America

Investigators: Elena N Thomas, Evan Tong, Vivin George

Kaiser Foundation Research Institute IRB #8 [Oakland / United States of America]

Inspection End Date: September 10, 2024

FEI: 2936498

Location: OAKLAND, CALIFORNIA, United States of America

Investigators: Kristin M Abaonza, Scott N Lim

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

Rechon Life Science AB [Malmö / Sweden]

Inspection End Date: September 6, 2024

FEI: 3002806978

Location: MALMÖ, SKÅNE LÄN, Sweden

Investigators: José E Meléndez, Amir Alavi

Padagis US LLC [Minneapolis / United States of America]

Inspection End Date: September 6, 2024

FEI: 2127022

Location: MINNEAPOLIS, MINNESOTA, United States of America

Investigators: Beatrix D Hippe

Advanced Rx Pharmacy of Tennessee, LLC [Nashville / United States of America]

Inspection End Date: September 6, 2024

FEI: 3017450153

Location: NASHVILLE, TENNESSEE, United States of America

Investigators: Brittny C Cargo

Lee Cranmer [Tucson / United States of America]

Inspection End Date: September 6, 2024

FEI: 3009200773

Location: TUCSON, ARIZONA, United States of America

Investigators: Alanna L Mussawwir Bias

3M Company [Columbia / United States of America]

Inspection End Date: September 6, 2024

FEI: 3003399824

Location: COLUMBIA, MISSOURI, United States of America

Investigators: Jacob G Lutz, Geoffrey K Kilili

Annovex Pharma, Inc. [Lorton / United States of America]

Inspection End Date: September 6, 2024

FEI: 3020928491

Location: LORTON, VIRGINIA, United States of America

Investigators: Yaharn Su, Tekalign Wondimu, Kara J Wright

Granules India Limited [Qutubullapur / India]

Inspection End Date: September 6, 2024

FEI: 3004097901

Location: QUTUBULLAPUR, TELANGANA, India

Investigators: Joseph A Piechocki, Pratik S Upadhyay, DDC

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

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

Inspection End Date: September 5, 2024

FEI: 2410853

Location: HAUPPAUGE, NEW YORK, United States of America

Investigators: Gabrielle J Swain

Inova Health Care Services [Sterling / United States of America]

Inspection End Date: September 4, 2024

FEI: 1177788

Location: STERLING, VIRGINIA, United States of America

Investigators: La Tasham Gunter

Diagnostica Stago, Inc. [Parsippany / United States of America]

Inspection End Date: September 4, 2024

FEI: 2245451

Location: PARSIPPANY, NEW JERSEY, United States of America

Investigators: Monica L Gutierrez

Signature Filling Company, LLC [Saint Louis / United States of America]

Inspection End Date: September 3, 2024

FEI: 3013141826

Location: SAINT LOUIS, MISSOURI, United States of America

Investigators: Mary L Schuckmann

Generitech Corporation [Fresno / United States of America]

Inspection End Date: September 3, 2024

FEI: 3002994577

Location: FRESNO, CALIFORNIA, United States of America

Investigators: John A Gonzalez

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

Oto Med Inc [Lake Havasu City / United States of America]

Inspection End Date: August 30, 2024

FEI: 2021687

Location: LAKE HAVASU CITY, ARIZONA, United States of America

Investigators: Scott D Stevens

ACINO PRODUCTS LIMITED LIABILITY COMPANY [Robbinsville / United States of America]

Inspection End Date: August 30, 2024

FEI: 3004723334

Location: ROBBINSVILLE, NEW JERSEY, United States of America

Investigators: David A Oluwo, Suchan Kim, Catherine O Lamptey

Profounda Inc [Orlando / United States of America]

Inspection End Date: August 30, 2024

FEI: 3011873350

Location: ORLANDO, FLORIDA, United States of America

Investigators: Saundrea A Munroe, Mabany Lizardi

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

The Snore Reliever Company LLC [North Bergen / United States of America]

Inspection End Date: August 29, 2024

FEI: 3008583502

Location: NORTH BERGEN, NEW JERSEY, United States of America

Investigators: Matthew T Sanchez

Blair M. Brengle, M.D. [Indianapolis / United States of America]

Inspection End Date: August 29, 2024

FEI: 3018034336

Location: INDIANAPOLIS, INDIANA, United States of America

Investigators: Corrine M Carter, Victoria R Flournoy

SmartSurg Medical Supply LLC [Frisco / United States of America]

Inspection End Date: August 29, 2024

FEI: 3011705333

Location: FRISCO, TEXAS, United States of America

Investigators: Michelle Paxon

Mega Sun Inc [Saint Louis / United States of America]

Inspection End Date: August 29, 2024

FEI: 3006190476

Location: SAINT LOUIS, MISSOURI, United States of America

Investigators: Edward E Lockwood (EEL)

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

Marwan M. Shaykh, M.D. dba Assisted Fertility Program [Jacksonville / United States of America]

Inspection End Date: August 28, 2024

FEI: 3005033067

Location: JACKSONVILLE, FLORIDA, United States of America

Investigators: Barbara T Carmichael

KC Pharmaceuticals, Inc. [Pomona / United States of America]

Inspection End Date: August 28, 2024

FEI: 2026940

Location: POMONA, CALIFORNIA, United States of America

Investigators: Ana Mariaa Plapcianu, Christopher R Czajka, Ngozi G Offor

Commonwealth of Massachusetts Dept of Mental Health CRRC [Boston / United States of America]

Inspection End Date: August 28, 2024

FEI: 3011071214

Location: BOSTON, MASSACHUSETTS, United States of America

Investigators: Meredith L Miller

Ferrera, R. David, MD [Sacramento / United States of America]

Inspection End Date: August 27, 2024

FEI: 3006792800

Location: SACRAMENTO, CALIFORNIA, United States of America

Investigators: Scott N Lim

Felix Generics Private Limited [Dhar Sub-District / India]

Inspection End Date: August 27, 2024

FEI: 3014281041

Location: DHAR SUB-DISTRICT, MADHYA PRADESH, India

Investigators: Kellia N Hicks

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

Mid-America Transplant Services [Saint Louis / United States of America]

Inspection End Date: August 23, 2024

FEI: 3001238381

Location: SAINT LOUIS, MISSOURI, United States of America

Investigators: Esther A Ofori

Countryside Feed, LLC [Hillsboro / United States of America]

Inspection End Date: August 23, 2024

FEI: 1920360

Location: HILLSBORO, KANSAS, United States of America

Investigators: Andrew K Schaal

Ivan Carreras, M.D. [Miami / United States of America]

Inspection End Date: August 23, 2024

FEI: 3031240307

Location: MIAMI, FLORIDA, United States of America

Investigators: Chantae D Mitchell

Kelyniam Global, Inc. [Collinsville / United States of America]

Inspection End Date: August 23, 2024

FEI: 3009424796

Location: COLLINSVILLE, CONNECTICUT, United States of America

Investigators: Katarzyna Plona

Little Rapids Corporation [Green Bay / United States of America]

Inspection End Date: August 23, 2024

FEI: 1000049086

Location: GREEN BAY, WISCONSIN, United States of America

Investigators: Ulysses D Singleton

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

BioLife Plasma Services L.P. (Baxalta US Inc.) [Bannockburn / United States of America]

Inspection End Date: August 22, 2024

FEI: 3016429887

Location: BANNOCKBURN, ILLINOIS, United States of America

Investigators: Kaarin M Slotte, Elias N Paz Alonzo, Celeta S Coves

Lin Fertility Network, Inc. [Corona / United States of America]

Inspection End Date: August 22, 2024

FEI: 3015368771

Location: CORONA, CALIFORNIA, United States of America

Investigators: Creighton T Tuzon

Midwest Dry Transload, Inc. [Galva / United States of America]

Inspection End Date: August 22, 2024

FEI: 3003242359

Location: GALVA, ILLINOIS, United States of America

Investigators: Mark G Peterson

Strata Skin Sciences, Inc. [Carlsbad / United States of America]

Inspection End Date: August 22, 2024

FEI: 3002942014

Location: CARLSBAD, CALIFORNIA, United States of America

Investigators: Sarah A Hassas

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

Bimeda, Inc. [Le Sueur / United States of America]

Inspection End Date: August 20, 2024

FEI: 2110168

Location: LE SUEUR, MINNESOTA, United States of America

Investigators: Lori B Wikstrom, Seneca D Toms

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

BioMarin Pharmaceutical Inc. [Novato / United States of America]

Inspection End Date: August 19, 2024

FEI: 3004079983

Location: NOVATO, CALIFORNIA, United States of America

Investigators: Jolanna A Norton

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

Chara Biologics, Inc. [Chatsworth / United States of America]

Inspection End Date: August 16, 2024

FEI: 3015265204

Location: CHATSWORTH, CALIFORNIA, United States of America

Investigators: Emily B Camire, Laurissa S Flowers

Belcher Pharmaceuticals, LLC [Largo / United States of America]

Inspection End Date: August 16, 2024

FEI: 1000526113

Location: LARGO, FLORIDA, United States of America

Investigators: Jessica P Mcalister, Kayla V Sprague

Bio Gen Technologies, Inc [Skaneateles / United States of America]

Inspection End Date: August 16, 2024

FEI: 3008140960

Location: SKANEATELES, NEW YORK, United States of America

Investigators: Wendy M Stone

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

DENTAL TECHNOLOGIES, INC. [Lincolnwood / United States of America]

Inspection End Date: August 14, 2024

FEI: 1413475

Location: LINCOLNWOOD, ILLINOIS, United States of America

Investigators: Nicholas Z Lu, Joohi Castelvetere, Michele L Glendenning

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

AIV, Inc [Harmans / United States of America]

Inspection End Date: August 12, 2024

FEI: 1121996

Location: HARMANS, MARYLAND, United States of America

Investigators: Jude C Dikes

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