Recently Published FDA Form 483s

RETROPERC [Passaic / United States of America]

Inspection End Date: December 18, 2024

FEI: 3019946783

Location: PASSAIC, NEW JERSEY, United States of America

Investigators: LT Colin E Tack, BSE

Stryker Neurovascular [Fremont / United States of America]

Inspection End Date: December 18, 2024

FEI: 3008853977

Location: FREMONT, CALIFORNIA, United States of America

Investigators: Kristin M Abaonza

Acella Pharmaceuticals, LLC [Alpharetta / United States of America]

Inspection End Date: December 18, 2024

FEI: 3006691461

Location: ALPHARETTA, GEORGIA, United States of America

Investigators: Matthew R Coleman

Arch Medical Solutions - Elkhart [Elkhart / United States of America]

Inspection End Date: December 18, 2024

FEI: 3009923627

Location: ELKHART, INDIANA, United States of America

Investigators: Suyang Qin

INMAN ORTHODONTIC LABORATORIES, INC. [Coral Springs / United States of America]

Inspection End Date: December 18, 2024

FEI: 3005663102

Location: CORAL SPRINGS, FLORIDA, United States of America

Investigators: David M Wilkinson

Millstone Medical Outsourcing, LLC [Fall River / United States of America]

Inspection End Date: December 18, 2024

FEI: 3003128516

Location: FALL RIVER, MASSACHUSETTS, United States of America

Investigators: Sara M Onyango

VARIAMED, L.L.C. [Chattanooga / United States of America]

Inspection End Date: December 18, 2024

FEI: 3010405322

Location: CHATTANOOGA, TENNESSEE, United States of America

Investigators: Jamie P Webb, Lashawn M Elam

Ramy A. Fayad, M.D. [Toledo / United States of America]

Inspection End Date: December 18, 2024

FEI: 3032576416

Location: TOLEDO, OHIO, United States of America

Investigators: Brittany M Kershaw

Chartwell Pharmaceuticals West Caldwell LLC [West Caldwell / United States of America]

Inspection End Date: December 18, 2024

FEI: 3005376609

Location: WEST CALDWELL, NEW JERSEY, United States of America

Investigators: Anthony J Donato, Rohan P Sridhar

Sterigenics International, LLC [Schaumburg / United States of America]

Inspection End Date: December 17, 2024

FEI: 1420032

Location: SCHAUMBURG, ILLINOIS, United States of America

Investigators: Nicholas Z Lu

Sun Scientific Inc [Dobbs Ferry / United States of America]

Inspection End Date: December 17, 2024

FEI: 3008773774

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

Investigators: Preston M Lee

Medynus, Inc. [Irvine / United States of America]

Inspection End Date: December 17, 2024

FEI: 3015426608

Location: IRVINE, CALIFORNIA, United States of America

Investigators: Kevin N Tran

MRPC [Butler / United States of America]

Inspection End Date: December 16, 2024

FEI: 3015239144

Location: BUTLER, WISCONSIN, United States of America

Investigators: Chad E Schmear

QUADRIC BIOMED, LLC [Colorado Springs / United States of America]

Inspection End Date: December 16, 2024

FEI: 3025467473

Location: COLORADO SPRINGS, COLORADO, United States of America

Investigators: Matthew M Vernon

XYRESIC LLC [Jackson / United States of America]

Inspection End Date: December 16, 2024

FEI: 3021588295

Location: JACKSON, MICHIGAN, United States of America

Investigators: Felicia E Armbrustmacher

Swiss-American CDMO, LLC [Carrollton / United States of America]

Inspection End Date: December 16, 2024

FEI: 3001451826

Location: CARROLLTON, TEXAS, United States of America

Investigators: Roy Baby, Elizabeth A Krolczyk

WAVi Co. [Denver / United States of America]

Inspection End Date: December 16, 2024

FEI: 3013757456

Location: DENVER, COLORADO, United States of America

Investigators: Christine I Shaw

AIRGAS USA, LLC [South Salt Lake / United States of America]

Inspection End Date: December 16, 2024

FEI: 1717226

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

MGH Gourmet, Inc. DBA Gourmet Foods [Compton / United States of America]

Inspection End Date: December 16, 2024

FEI: 3000215847

Location: COMPTON, CALIFORNIA, United States of America

Investigators: Ashley S Ertzman, Phillip J Sample, Angelica Ornelas

GMP Laboratories of America Inc [Anaheim / United States of America]

Inspection End Date: December 16, 2024

FEI: 3002710875

Location: ANAHEIM, CALIFORNIA, United States of America

Investigators: Tiara Nbrown Crosen, Gunneet Kaur

Ohio Pet Foods, Inc. [Lisbon / United States of America]

Inspection End Date: December 13, 2024

FEI: 1000482018

Location: LISBON, OHIO, United States of America

Investigators: Lisa M Marko

Epicare Acquisitions, Llc [Lawrence Township / United States of America]

Inspection End Date: December 13, 2024

FEI: 3015730775

Location: LAWRENCE TOWNSHIP, NEW JERSEY, United States of America

Investigators: William R Chang

Amrut Ambardekar, M.D. [Aurora / United States of America]

Inspection End Date: December 13, 2024

FEI: 3032733095

Location: AURORA, COLORADO, United States of America

Investigators: Audrey J Yarbrough

MedShift [Charlotte / United States of America]

Inspection End Date: December 13, 2024

FEI: 3013462594

Location: CHARLOTTE, NORTH CAROLINA, United States of America

Investigators: Gamal A Norton

Beckman Coulter, Inc. [Chaska / United States of America]

Inspection End Date: December 13, 2024

FEI: 2122870

Location: CHASKA, MINNESOTA, United States of America

Investigators: Albert L Nguyen

Pfizer Inc. Groton Laboratories [Groton / United States of America]

Inspection End Date: December 13, 2024

FEI: 1216806

Location: GROTON, CONNECTICUT, United States of America

Investigators: Matthew C Watson, Erin M Mcdowell

Baxter Healthcare (Guangzhou) Co., Ltd [Guangzhou / China]

Inspection End Date: December 13, 2024

FEI: 3012476520

Location: GUANGZHOU, GUANGDONG, China

Investigators: Amir Alavi, Dipesh K Shah, Saleem A Akhtar

Biomat USA, Inc. [Terre Haute / United States of America]

Inspection End Date: December 13, 2024

FEI: 3006811800

Location: TERRE HAUTE, INDIANA, United States of America

Investigators: Lesley Maep Lutao, David A Moore

Baxter Healthcare SA [Singapore / Singapore]

Inspection End Date: December 13, 2024

FEI: 3002806460

Location: SINGAPORE, SINGAPORE, Singapore

Investigators: Tamil Arasu, PhD, David J Gomes, Wayne D Mcgrath

QUALI CONTROLE [Méru / France]

Inspection End Date: December 13, 2024

FEI: 3002807958

Location: MÉRU, HAUTS-DE-FRANCE, France

Investigators: Lisa R Hilliar

Genus Lifesciences Inc. [Allentown / United States of America]

Inspection End Date: December 13, 2024

FEI: 3014677161

Location: ALLENTOWN, PENNSYLVANIA, United States of America

Investigators: Mindy M Chou, Azeezat M Lawal, Evan Tong, Paige R Mccoy

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

Inspection End Date: December 12, 2024

FEI: 1000136478

Location: CHESTER, NEW YORK, United States of America

Investigators: Kwong P Lee

Roger S. Keresztes, M.D. [Stony Brook / United States of America]

Inspection End Date: December 12, 2024

FEI: 3015471867

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

Investigators: Bernardica T Sculac Stern

Jamol Laboratories, Inc. [Emerson / United States of America]

Inspection End Date: December 12, 2024

FEI: 2211383

Location: EMERSON, NEW JERSEY, United States of America

Investigators: Jessica S Estriplet, Emmanuel T Donyina

DO & CO New York Catering, Inc. [South Ozone Park / United States of America]

Inspection End Date: December 12, 2024

FEI: 3002903191

Location: SOUTH OZONE PARK, NEW YORK, United States of America

Investigators: Robert E Moncayo, Jung K Kim, Affiong Flores, Armia A Beshay, Melissa N Gregorio, Sonia E Ortiz, Devon O Seymour, Dana A Razzano, Nur M Faisal

PLUS EV HOLDINGS INC [Kansas City / United States of America]

Inspection End Date: December 12, 2024

FEI: 3011630465

Location: KANSAS CITY, MISSOURI, United States of America

Investigators: Eric C Fox

Richie Pharmacal Company Inc [Glasgow / United States of America]

Inspection End Date: December 12, 2024

FEI: 1025513

Location: GLASGOW, KENTUCKY, United States of America

Investigators: Paranthaman Senthamaraikannan, Brandy Edmonds

K.B. Specialty Foods [Greensburg / United States of America]

Inspection End Date: December 12, 2024

FEI: 1824516

Location: GREENSBURG, INDIANA, United States of America

Investigators: Edwardstine J Reese, Tessy O Martins, Jennifer R Johnson, Suzette M Kuhn

Dharma Research, Inc. [Miami / United States of America]

Inspection End Date: December 11, 2024

FEI: 3010131268

Location: MIAMI, FLORIDA, United States of America

Investigators: Ronald Ifraimov

MURATA VIOS, INC [Saint Paul / United States of America]

Inspection End Date: December 11, 2024

FEI: 3015328411

Location: SAINT PAUL, MINNESOTA, United States of America

Investigators: Tyler R Courtney

Turncare, Inc [Pompton Plains / United States of America]

Inspection End Date: December 11, 2024

FEI: 3013682457

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

Investigators: Monica L Gutierrez

Pantheon Spinal LLC [Austin / United States of America]

Inspection End Date: December 11, 2024

FEI: 3010665091

Location: AUSTIN, TEXAS, United States of America

Investigators: Amber Smith

Ikonisys Inc. [New Haven / United States of America]

Inspection End Date: December 10, 2024

FEI: 3005566046

Location: NEW HAVEN, CONNECTICUT, United States of America

Investigators: Katarzyna Plona

Tim Smith, M.D. [Cincinnati / United States of America]

Inspection End Date: December 10, 2024

FEI: 3031869799

Location: CINCINNATI, OHIO, United States of America

Investigators: Kathryn L Suttling

Vee Pak, LLC dba Voyant Beauty [Hodgkins / United States of America]

Inspection End Date: December 10, 2024

FEI: 3005163279

Location: HODGKINS, ILLINOIS, United States of America

Investigators: Michael A Charles, Angela C Welker, Jean Claude Garay

Evonik Corporation [Birmingham / United States of America]

Inspection End Date: December 10, 2024

FEI: 3012757951

Location: BIRMINGHAM, ALABAMA, United States of America

Investigators: Camerson E Moore

STABILIZ ORTHOPAEDICS [Downingtown / United States of America]

Inspection End Date: December 9, 2024

FEI: 3014104093

Location: DOWNINGTOWN, PENNSYLVANIA, United States of America

Investigators: Nadia R Barreda

Cetylite Industries, Inc. [Pennsauken / United States of America]

Inspection End Date: December 9, 2024

FEI: 2242327

Location: PENNSAUKEN, NEW JERSEY, United States of America