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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
5/19/2025BAYER DE MEXICO

Ciudad De Mexico

MEXICOANALGESIC, N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
5/19/2025Genesis Seating

Grand Rapids

UNITED STAANTI-TUSSIVE/COLD N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
5/19/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
5/19/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
5/19/2025PASCUAL LABORATORIES

Kalakhang Manila

PHILIPPINEANTI-ASTHMATIC, N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
5/19/2025ABBOTT INDIA LIMITED

MUMBAI

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
5/19/2025HUBIHOL, UAB

Vilnius

LITHUANIAFENBENDAZOLE (ANTIPARASITIC)
118NOT LISTED
3280FRNMFGREG
+1 more
5/19/2025LABORATORIO CUBARBS S.R.L.

Canabacoa

DOMINICAN ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN)
118NOT LISTED
3280FRNMFGREG
+1 more
5/19/2025MUNDIPHARMA

Petaling Jaya Selangor De

MALAYSIAANTI-MICROBIAL N.E.C.
118NOT LISTED
3280FRNMFGREG
5/19/2025KELI

Tirana

ALBANIASEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
3260NO ENGLISH
5/19/2025DYNAMIC GROUP

Laval

CANADATIRZEPATIDE (ANTI-DIABETIC)
118NOT LISTED
2280DIRSEXMPT
+1 more
5/19/2025GUANGZHOU PLUSLIFE BIOTECH CO. LTD.

Guangzhou

CHINACOVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES
118NOT LISTED
237NO PMA
+2 more
5/19/2025GUANGZHOU SHIYI TECHNOLOGY CO.,

Guangzhou

CHINART-PCR MULTIGENE EXPRESSION TEST, SENTINEL LYMPH NODE, CANCER METASTASIS DETECTION
118NOT LISTED
237NO PMA
+2 more
5/19/2025MR SANICOM GMBH

Munich

GERMANYCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE
118NOT LISTED
237NO PMA
+3 more
5/19/2025SAFECARE

Hangzhou

CHINACOVID-19 MULTI-ANALYTE ANTIGEN DEVICE
118NOT LISTED
237NO PMA
+3 more
5/19/2025SAFECARE

Hangzhou

CHINACORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
118NOT LISTED
237NO PMA
+3 more
5/19/2025DERMAX CO LTD

Shijiazhuang City

CHINAIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
5/19/2025JETEMA CO LTD

Yongin

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
5/19/2025ACROSS CO. LTD

Gwangwon

SOUTH KORENON-STAINLESS STEEL NEEDLE
118NOT LISTED
237NO PMA
+2 more
5/19/2025BNC Korea Inc.

Dalseo

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
5/19/2025VENUGOPALAN CHODON PUTHIYOTH

Cannanore

INDIAASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
118NOT LISTED
75UNAPPROVED
5/19/2025VENUGOPALAN CHODON PUTHIYOTH

Cannanore

INDIAANTI-INFLAMMATORY N.E.C.
118NOT LISTED
75UNAPPROVED
5/19/2025VENUGOPALAN CHODON PUTHIYOTH

Cannanore

INDIAFOLIC ACID (VITAMIN)
118NOT LISTED
75UNAPPROVED
5/19/2025VENUGOPALAN CHODON PUTHIYOTH

Cannanore

INDIATRIBULUS (HERBAL & BOTANICALS, NOT TEAS)
118NOT LISTED
75UNAPPROVED
5/19/2025VED LIFEGAVES PTD

DehraduN

INDIASILDENAFIL CITRATE (REGULATOR)
118NOT LISTED
75UNAPPROVED
5/19/2025SANDU PHARMACEUTICALS

Bardez

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
75UNAPPROVED
5/19/2025BHATTA RAMESH BABU

Hyderabad

INDIASODIUM BICARBONATE (REPLENISHER)
118NOT LISTED
75UNAPPROVED
5/19/2025PANKAJ NARAYANBHAI DARJI

Gandhinagar

INDIAINSULIN (INJ) (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
5/19/2025SWADESHI EXIM PRIVATE LIMITED

Noida

INDIAACETAMINOPHEN (ANALGESIC)
118NOT LISTED
75UNAPPROVED
5/17/2025ZENITH DRINKS PVT LTD

New Delhi

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
5/17/2025Aft Pharmaceuticals Ltd

Auckland

NEW ZEALANANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
5/16/2025LIVE BIO PHARMA

Kerla

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/16/2025ALKEM HEALTH SCIENCE

Namthang

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/16/2025SAMARTH LIFE SCIENCES PVT LTD

Mumbai

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/16/2025Laboratoire Unither

Coutances

FRANCEMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/16/2025U inquest biotech

Hyderabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/16/2025MEDICANT NUTRIENTS

Barhi

INDIABIOTIN (VITAMIN H, COENZYME R)
75UNAPPROVED
5/16/2025Shreya Life Science Pvt Ltd

Uttarakhand

INDIAVITAMIN B2 (RIBOFLAVIN)
75UNAPPROVED
5/16/2025J.B. Chemicals & Pharmaceuticals Ltd.

Ankleshwar

INDIAMETRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
5/16/2025Belupo Pharmaceuticals And Cosmetic Inc

Koprivnica

CROATIABETAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
5/16/2025Productos Maver, S.A. de C.V.

Tlaquepaque

MEXICOMELOXICAM (ANTI-INFLAMMATORY, PART II)
75UNAPPROVED
5/16/2025Productos Farmaceuticos Collins, S.A. De C.V.

Guadalajara

MEXICOANALGESIC, N.E.C.
75UNAPPROVED
5/16/2025LABORATORIOS YEALDI PHARMA SA DE

San Lorenzo Toxico

MEXICOMAGNESIUM CITRATE(SOL) (CATHARTIC)
75UNAPPROVED
5/16/2025SYDENHAM LABORATORIO

Puebla

MEXICOFOLIC ACID (VITAMIN)
75UNAPPROVED
5/16/2025BRULUAGSA SA DE CV

Atlancomulco

MEXICOVITAMIN B1 (THIAMINE)
75UNAPPROVED
5/16/2025MANUFACTURAS NATUREX, S.A. DE C.V.

TLAQUEPAQUE

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/16/2025CIPLA LIMITED

Mumbai

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/16/2025Glaxosmithkline Pharmaceuticals

Mumbai

INDIAALBENDAZOLE (ANTIPARASITIC)
75UNAPPROVED
5/16/2025Jamp Pharma Corp

Boucherville

CANADAESCITALOPRAM OXALATE
75UNAPPROVED
5/16/2025FOURCOMPANY CO LTD

Seoul

SOUTH KOREHOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN)
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 15 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 75 (UNAPPROVED), 3260 (NO ENGLISH), 2280 (DIRSEXMPT) and 3 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 514 of 10,077 • Showing records 25,651-25,700 of 503,850 total