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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
6/4/2025SSL Manufacturing (Thailand) LTD.

Bang Pakong

THAILANDCONDOM
2780DEVICEGMPS
6/4/2025SSL Manufacturing (Thailand) LTD.

Bang Pakong

THAILANDCONDOM
2780DEVICEGMPS
6/4/2025Hisun Pharmaceutical Co Ltd

Shanghai

CHINATACROLIMUS (IMMUNOSUPPRESSIVE)
2280DIRSEXMPT
6/4/2025SSL Manufacturing (Thailand) LTD.

Bang Pakong

THAILANDCONDOM
477HOLES
6/4/2025SSL Manufacturing (Thailand) LTD.

Bang Pakong

THAILANDCONDOM
477HOLES
6/4/2025SSL Manufacturing (Thailand) LTD.

Bang Pakong

THAILANDCONDOM
477HOLES
6/4/2025SSL Manufacturing (Thailand) LTD.

Bang Pakong

THAILANDCONDOM
477HOLES
6/4/2025SSL Manufacturing (Thailand) LTD.

Bang Pakong

THAILANDCONDOM, NON-LATEX
477HOLES
6/4/2025SSL Manufacturing (Thailand) LTD.

Bang Pakong

THAILANDCONDOM
477HOLES
6/4/2025XINGFUJING JEWELRY LTD. CO

Fuzhou

CHINATOY, NOVELTY, PLAY LASER PRODUCT
476NO REGISTR
6/4/2025Industria Farmaceutica, S.A.

Mixco

GUATEMALAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
473LABELING
488HEALTH C
6/4/2025Foppen Paling En Zalm B.V.

Harderwijk

NETHERLANDSALMON (HUMPBACK, SILVER, KING, SOCKEYE, ETC.), COLD SMOKED, FISH
295LISTERIA
6/4/2025Olympic Eel & Salmon Industries SA

Preveza

GREECESALMON (HUMPBACK, SILVER, KING, SOCKEYE, ETC.), COLD SMOKED, FISH
295LISTERIA
6/4/2025NIPRO THAILAND CORP LTD

Ayuthaya

THAILANDSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
290DE IMP GMP
6/4/2025NIPRO THAILAND CORP LTD

Ayuthaya

THAILANDCATHETER, INTRAVASCULAR, SHORT TERM
290DE IMP GMP
6/4/2025NIPRO THAILAND CORP LTD

Ayuthaya

THAILANDTUBING, FLUID DELIVERY
290DE IMP GMP
6/4/2025P.T. Nipro Indonesia Jaya

Karawang

INDONESIASET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
290DE IMP GMP
6/4/2025P.T. Nipro Indonesia Jaya

Karawang

INDONESIASET, DIALYSIS, SINGLE NEEDLE WITH UNI-DIRECTIONAL PUMP
290DE IMP GMP
6/4/2025Mars Wrigley Confectionery (China) Limited

Guangzhou

CHINAFLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
256INCONSPICU
482NUTRIT LBL
6/4/2025Pescaradolc Srl

Spoltore

ITALYPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
256INCONSPICU
473LABELING
+1 more
6/4/2025Pescaradolc Srl

Spoltore

ITALYPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
256INCONSPICU
473LABELING
+1 more
6/4/2025Pescaradolc Srl

Spoltore

ITALYPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
256INCONSPICU
473LABELING
+1 more
6/4/2025Pescaradolc Srl

Spoltore

ITALYPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
256INCONSPICU
473LABELING
+1 more
6/4/2025SPREADIES PTY LTD

Leichhardt

AUSTRALIAYOGURT (PLAIN, FLAVORED OR FRUIT ADDED)
249FILTHY
6/4/2025Weifang Yibao Foodstuff Co., Ltd.

Anqiu City

CHINAGINGER ROOT (ROOT & TUBER VEGETABLE)
249FILTHY
6/4/2025Weifang Yibao Foodstuff Co., Ltd.

Anqiu City

CHINAGINGER ROOT (ROOT & TUBER VEGETABLE)
249FILTHY
6/4/2025RISING RAINBOW WORLDWIDE

Pune

INDIAMANGO (SUBTROPICAL AND TROPICAL FRUIT)
241PESTICIDE
6/4/2025RISING RAINBOW WORLDWIDE

Pune

INDIAMANGO (SUBTROPICAL AND TROPICAL FRUIT)
241PESTICIDE
6/4/2025RISING RAINBOW WORLDWIDE

Pune

INDIAMANGO (SUBTROPICAL AND TROPICAL FRUIT)
241PESTICIDE
6/4/2025RISING RAINBOW WORLDWIDE

Pune

INDIAMANGO (SUBTROPICAL AND TROPICAL FRUIT)
241PESTICIDE
6/4/2025Gia Minh Co., Ltd.

Ho Chi Minh

VIETNAMSUBTROPICAL AND TROPICAL FRUIT, N.E.C.
241PESTICIDE
6/4/2025sajni tradelink

Ahmedabad

INDIABEAN, CORN, PEA, DRIED OR PASTE, N.E.C. (VEGETABLE)
241PESTICIDE
6/4/2025QUYNH ANH AQUATIC PRODUCT IMPORT EXPORT BUSINESS COMPANY LIMITED

Thu Duc

VIETNAMMUSHROOM, STRAW, FUNGI PRODUCTS, N.E.C.
241PESTICIDE
6/4/2025Hindustan Unilever Limited

Mumbai

INDIABATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
3881COSMETFPLA
6/4/2025EISUNGRAIN(SHANDONG) ECO TECHNOLOGY CO., LTD.

Zibo

CHINATAMPON, MENSTRUAL, UNSCENTED
118NOT LISTED
3280FRNMFGREG
+2 more
6/4/2025ALTRUAN

Massing

GERMANYSYRINGE, PISTON
118NOT LISTED
3280FRNMFGREG
+1 more
6/4/2025ALTRUAN

Massing

GERMANYTAPE AND BANDAGE, ADHESIVE
118NOT LISTED
3280FRNMFGREG
+1 more
6/4/2025CARDIMED ASIA MEDI

Atasehir

TURKEYCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE
118NOT LISTED
3280FRNMFGREG
+2 more
6/4/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
6/4/2025BROSCARGO INT'L CO., LTD.

Seo

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
6/4/2025HALEON

Mississauga

CANADAACETAMINOPHEN (ANALGESIC)
118NOT LISTED
3280FRNMFGREG
6/4/2025Guangzhou Ronghui Cosmetics Co., Ltd.

Guangzhou

CHINAONABOTULINUMTOXINA
118NOT LISTED
3260NO ENGLISH
+2 more
6/4/2025DAEWOONG PHARMACEUTICAL CO LTD

SEOUL

SOUTH KOREONABOTULINUMTOXINA
118NOT LISTED
3260NO ENGLISH
+2 more
6/4/2025E-FILLERS SA

Athens

GREECEOTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
237NO PMA
+1 more
6/4/2025Hugel, Inc.

Chuncheon-si

SOUTH KORELIDOCAINE
118NOT LISTED
237NO PMA
+1 more
6/4/2025KRUNAK AHIRE

Ahmedabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/4/2025Dr. Anand Rane

Maharashtra

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/4/2025Dr. Anand Rane

Maharashtra

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/4/2025PROCTOR AND GAMBLE MANUFACTURING

Ahmedabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/4/2025RECKITT BENCKISER HEALTHCARE INDIA

Haryana 1220

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 2780 (DEVICEGMPS), 2280 (DIRSEXMPT), 477 (HOLES), 476 (NO REGISTR), 473 (LABELING) and 18 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 476 of 10,077 • Showing records 23,751-23,800 of 503,850 total