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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
7/3/2025REGAL BELOIT DE GUADALAJARA

El Salto

MEXICOGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
7/3/2025ITI

Anyang

SOUTH KOREGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
7/3/2025Jerusalem Pharmaceutical Co Ltd

Palestine

ISRAELMISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
7/3/2025RANCHO EL COCO

Rancheria Cerro De Aguilar

MEXICOPAPAYA (PAPAW) (SUBTROPICAL AND TROPICAL FRUIT)
9SALMONELLA
7/3/2025QUYNH ANH AQUATIC PRODUCT IMPORT EXPORT BUSINESS COMPANY LIMITED

Thu Duc

VIETNAMCLAMS
9SALMONELLA
7/3/2025Ahmad M.S. Al Dirani & Bros

Bekaa

LEBANONVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
256INCONSPICU
482NUTRIT LBL
+1 more
7/3/2025APOLLO TRADE

1505 Bureau C 1801 Nive

ALGERIANUT SPREADS WITH FLAVORINGS (E.G. NUTELLA)
256INCONSPICU
328USUAL NAME
7/3/2025Shanghai Helplifes Technology Co.,

Shanghai

CHINAMILK AND MILK PRODUCTS, ADDED SAFE AND SUITABLE MICROBIAL ORGANISMS (E.G. LACTOBACILLUS ACIDOPHILUS)
251POISONOUS
7/3/2025USHA KIRANA STORE

Telangana

INDIATAMARIND, DRIED OR PASTE
249FILTHY
7/3/2025PUTCHAKAYALA SRINIVASARAO

Krishna

INDIATAMARIND, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED
249FILTHY
7/3/2025VIJAY ENTERPRISES

Ulhasnagar

INDIAOTHER BAKERY PRODUCTS, N.E.C.
249FILTHY
7/3/2025VIJAY ENTERPRISES

Ulhasnagar

INDIAOTHER BAKERY PRODUCTS, N.E.C.
249FILTHY
7/3/2025MODESTA SALAZAR ALEJANDRO

Acatzingo

MEXICOPRICKLE PEAR (CORE FRUIT)
241PESTICIDE
7/3/2025FUSION FOODS SAC

Lima

PERUPEPPER, SWEET (FRUIT USED AS VEGETABLE)
241PESTICIDE
7/3/2025Capital Ventures Pvt Ltd

New Delhi

INDIARICE, BASMATI, PROCESSED (PACKAGED)
241PESTICIDE
7/3/2025Capital Ventures Pvt Ltd

New Delhi

INDIARICE, BASMATI, PROCESSED (PACKAGED)
241PESTICIDE
7/3/2025GOLD HEALTH MANUF TRADING & SERV

Ho Chi Minh

VIETNAMEDIBLE BIRD'S NEST, READY-TO-EAT (MULTIPLE FOOD SPECIALTIES, SIDE DISHES & DESSERTS)
218LIST INGRE
321LACKS N/C
+2 more
7/3/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
118NOT LISTED
3280FRNMFGREG
+3 more
7/3/2025W CONCEPT

Gimpo

SOUTH KOREFOCUSED ULTRASOUND SYSTEM FOR NON-THERMAL, MECHANICAL TISSUE ABLATION
118NOT LISTED
3280FRNMFGREG
+1 more
7/3/2025Reckitt Banckiser Plc

Slough

UNITED KINLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE
118NOT LISTED
3280FRNMFGREG
+1 more
7/3/2025NAM A DENTAL MEDICINE COMPANY LIMITED

Ho Chi Minh

VIETNAMALIGNER, SEQUENTIAL
118NOT LISTED
3280FRNMFGREG
+2 more
7/3/2025SUNWIN BEAUTY FACT

Guangzhou

CHINAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
3280FRNMFGREG
+2 more
7/3/2025RWD LIFE SCIENCE CO

Shenzhen

CHINAPUMP, INFUSION OR SYRINGE, EXTRA-LUMINAL
118NOT LISTED
3280FRNMFGREG
+1 more
7/3/2025RWD LIFE SCIENCE CO

Shenzhen

CHINAPUMP, INFUSION OR SYRINGE, EXTRA-LUMINAL
118NOT LISTED
3280FRNMFGREG
+1 more
7/3/2025GLOBAL-E C/O SWATI COSMETICS

Skurup

SWEDENLENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
3280FRNMFGREG
7/3/2025FARMAMEDICA SA

Guatemala

GUATEMALASYRINGE, PISTON
118NOT LISTED
3280FRNMFGREG
7/3/2025DONGGUAN GUSIIE PROTECTIVE PRODUCTS CO., LTD.

Dongguan

CHINAGLOVE, PATIENT EXAMINATION, POLY
118NOT LISTED
3280FRNMFGREG
7/3/2025BIGFA JOINT STOCK COMPANY

Luong Son District

VIETNAMIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
2480RXPERSONAL
+4 more
7/3/2025FM MEIN ARZTBEDARF GMBH

Hall In Tirol

AUSTRIAOVER-THE-COUNTER MOLECULAR TEST TO DETECT SARS-COV-2
118NOT LISTED
508NO 510(K)
7/3/2025Surgicon & Cia

Cundinamarca

COLOMBIACATHETER, EMBOLECTOMY
118NOT LISTED
508NO 510(K)
7/3/2025Surgicon & Cia

Cundinamarca

COLOMBIACATHETER, EMBOLECTOMY
118NOT LISTED
508NO 510(K)
7/3/2025COSMAX, INC.

Hwaseong-si

SOUTH KOREZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN)
118NOT LISTED
7/3/2025SN PHARMACEUTICALS

Mumbai

INDIAANTI-HISTAMINIC N.E.C.
75UNAPPROVED
7/3/2025BAYER CONSUMER CARE AG

Basel

BRAZILEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
7/3/2025FRAN TAILOR

Winnipeg

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
7/3/2025JUVVADI RAJESHWAR RAO

Hyderabad

INDIAMILK THISTLE
75UNAPPROVED
7/3/2025JUVVADI RAJESHWAR RAO

Hyderabad

INDIABROMHEXINE HCL (EXPECTORANT)
75UNAPPROVED
7/3/2025JUVVADI RAJESHWAR RAO

Hyderabad

INDIAMAGNESIUM HYDROXIDE (ANTACID)
75UNAPPROVED
7/3/2025CESAR RODRIGUEZ CRUZ

Irapuato

MEXICOIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
7/3/2025CESAR RODRIGUEZ CRUZ

Irapuato

MEXICOFENOFIBRATE (ANTI-CHOLESTEREMIC)
75UNAPPROVED
7/3/2025CESAR RODRIGUEZ CRUZ

Irapuato

MEXICOAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
7/3/2025HONG KONG ZOEY TRADING CO.,LIMITED

Hong Kong

HONG KONGEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
7/3/2025HONG KONG ZOEY TRADING CO.,LIMITED

Hong Kong

HONG KONGEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
7/3/2025SWEETCARE LDA

Porto

PORTUGALDEXPANTHENOL (CHOLINERGIC)
75UNAPPROVED
7/3/2025Ghimas Spa

Casalecchio D

ITALYMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025LABORATORIOS DE FUERZA DE LA SALUD S.A DE CV

Distrito Federal

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025ZENITH DRINKS PVT LTD

New Delhi

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
7/3/2025JOSE OROZCO HERNANDEZ

Zapopan

MEXICOALOE (HERBAL AND BOTANICAL (NOT TEAS) II (CONTINUED))
75UNAPPROVED
7/3/2025M/S Jagsonpal Exports India Pvt. Ltd.

Delhi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025Novo Nordisk

West Sussex

UNITED KINSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 20 countries. Records on this page involve violations including 47 (NON STD), 27 (DRUG GMPS), 9 (SALMONELLA), 256 (INCONSPICU), 482 (NUTRIT LBL) and 17 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 422 of 10,077 • Showing records 21,051-21,100 of 503,850 total