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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
2/6/2025ARMSTRONG LABORATORIES MEXICO SA

Ciudad De Mexico

MEXICONEOMYCIN (AMINOGLYCOSIDES)
75UNAPPROVED
2/6/2025Laboratorios Raam De Sahuayo S A

Michoacan

MEXICOCLINDAMYCIN PHOSPHATE (LINCOMYCINS)
75UNAPPROVED
2/6/2025SUN PHARMA IND LTD

East Sikkim

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
2/6/2025LIFEVISION HEALTHCARE

Chandigarh

INDIAMULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
75UNAPPROVED
2/6/2025MEDISHRI HEALTHCARE

Delhi

INDIAALCLOFENAC (ANTI-INFLAMMATORY)
75UNAPPROVED
2/6/2025Wockhardt Ltd.

Mumbai

INDIAMECOBALAMIN (VITAMIN)
75UNAPPROVED
2/6/2025MEDISHRI HEALTHCARE

Delhi

INDIAANTACID, N.E.C.
75UNAPPROVED
2/6/2025Alkem Laboratories Ltd

Mumbai

INDIAMINOXIDIL (ANTI-HYPERTENSIVE)
75UNAPPROVED
2/6/2025GARY PHARMACEUTICALS P LIMITED

Punjab

INDIAMINOXIDIL (ANTI-HYPERTENSIVE)
75UNAPPROVED
2/6/2025AYURVEDIC UPCHAR KENDRA

Gujarat

INDIAANTI-DIABETIC N.E.C.
75UNAPPROVED
2/6/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREMOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
2/6/2025Nasco (UK)

Southall

UNITED KINBEAN, CORN, PEA, DRIED OR PASTE, N.E.C. (VEGETABLE)
62NEEDS FCE
83NO PROCESS
2/6/2025AKRON FORMULATIONS INDIA PRIVATE LIMITED

Hyderabad

INDIASENNA (CATHARTIC)
27DRUG GMPS
2/6/2025AKRON FORMULATIONS INDIA PRIVATE LIMITED

Hyderabad

INDIASENNA (CATHARTIC)
27DRUG GMPS
2/6/2025AKRON FORMULATIONS INDIA PRIVATE LIMITED

Hyderabad

INDIADIPHENHYDRAMINE HCL (ANTI-HISTAMINIC)
27DRUG GMPS
2/6/2025AKRON FORMULATIONS INDIA PRIVATE LIMITED

Hyderabad

INDIAANTI-BACTERIAL, N.E.C.
27DRUG GMPS
2/6/2025AKRON FORMULATIONS INDIA PRIVATE LIMITED

Hyderabad

INDIAANTI-BACTERIAL, N.E.C.
27DRUG GMPS
2/6/2025AKRON FORMULATIONS INDIA PRIVATE LIMITED

Hyderabad

INDIAACETAMINOPHEN (ANALGESIC)
27DRUG GMPS
2/6/2025AKRON FORMULATIONS INDIA PRIVATE LIMITED

Hyderabad

INDIAACETAMINOPHEN (ANALGESIC)
27DRUG GMPS
2/6/2025Nutri-Asia, Inc

Tagiug City

PHILIPPINEBANANA SAUCE
11UNSAFE COL
2/5/2025Thong Hong Company Limited

Ho Chi Minh City

VIETNAMPALM NUT (PALM FRUIT, SUGAR PALM) (SUBTROPICAL AND TROPICAL FRUIT)
3878POISONORD
2/5/2025CHANGSHA XUNMING TRADE CO LTD

Changsha

CHINAE-CIGARETTE
3842TP NO PMTA
3843TP NO SE
2/5/2025CHANGSHA XUNMING TRADE CO LTD

Changsha

CHINAE-CIGARETTE
3842TP NO PMTA
3843TP NO SE
2/5/2025CHANGSHA XUNMING TRADE CO LTD

Changsha

CHINAE-CIGARETTE
3842TP NO PMTA
3843TP NO SE
2/5/2025CHANGSHA XUNMING TRADE CO LTD

Changsha

CHINAE-CIGARETTE
3842TP NO PMTA
3843TP NO SE
2/5/2025CHANGSHA XUNMING TRADE CO LTD

Changsha

CHINAE-CIGARETTE
3842TP NO PMTA
3843TP NO SE
2/5/2025CHANGSHA XUNMING TRADE CO LTD

Changsha

CHINAE-CIGARETTE
3842TP NO PMTA
3843TP NO SE
2/5/2025CHANGSHA XUNMING TRADE CO LTD

Changsha

CHINAE-CIGARETTE
3842TP NO PMTA
3843TP NO SE
2/5/2025CHANGSHA XUNMING TRADE CO LTD

Changsha

CHINAE-CIGARETTE
3842TP NO PMTA
3843TP NO SE
2/5/2025CHANGSHA XUNMING TRADE CO LTD

Changsha

CHINAE-CIGARETTE
3842TP NO PMTA
3843TP NO SE
2/5/2025CHANGSHA XUNMING TRADE CO LTD

Changsha

CHINAE-CIGARETTE
3842TP NO PMTA
3843TP NO SE
2/5/2025CHANGSHA XUNMING TRADE CO LTD

Changsha

CHINAE-CIGARETTE
3842TP NO PMTA
3843TP NO SE
2/5/2025CHANGSHA XUNMING TRADE CO LTD

Changsha

CHINAE-CIGARETTE
3842TP NO PMTA
3843TP NO SE
2/5/2025SHENZHEN WELLS OPTOELECTRONICS C

Shenzhen

CHINAMASSAGER, THERAPEUTIC, ELECTRIC
3280FRNMFGREG
341REGISTERED
2/5/2025Baxter Healthcare Corporation

Skaneateles Falls

UNITED STAELECTROCARDIOGRAPH
3280FRNMFGREG
2/5/2025Unilever Lever Faberge Deutschland

Mannheim

GERMANYBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
3200COSM MISB2
2/5/2025Unilever Lever Faberge Deutschland

Mannheim

GERMANYBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
3200COSM MISB2
2/5/2025Unilever Lever Faberge Deutschland

Mannheim

GERMANYBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
3200COSM MISB2
2/5/2025Seiki, Inc.

Kagoshima-shi

JAPANYELLOWTAIL, AMBERJACK
2860VETDRUGRES
2/5/2025Seiki, Inc.

Kagoshima-shi

JAPANYELLOWTAIL, AMBERJACK
2860VETDRUGRES
2/5/2025BASEAFOOD HOCHIMINH BRANCH

HOCHIMINH CITY

VIETNAMMACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22')
2580MFRHACCP
306INSANITARY
2/5/2025SOCIETE DE CONSERVERIE EN AFRIQUE (SCA S.A.)

Dakar

SENEGALTUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
2360HISTAMINE
2/5/2025SOCIETE DE CONSERVERIE EN AFRIQUE (SCA S.A.)

Dakar

SENEGALTUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
2360HISTAMINE
2/5/2025SOCIETE DE CONSERVERIE EN AFRIQUE (SCA S.A.)

Dakar

SENEGALTUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
2360HISTAMINE
2/5/2025THE 8TH ELEMENT

Cape Town

SOUTH AFRIVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
260FALSE
+2 more
2/5/2025THE 8TH ELEMENT

Cape Town

SOUTH AFRIVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
260FALSE
+2 more
2/5/2025THE 8TH ELEMENT

Cape Town

SOUTH AFRIVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
260FALSE
+2 more
2/5/2025Beijing ADSS Development Co., Ltd.

Beijing

CHINAPOWERED LASER SURGICAL INSTRUMENTS
508NO 510(K)
2/5/2025MONDELEZ MEXICO S DE RL DE CV

Gustavo a. Madero

MEXICOANTI-TUSSIVE/COLD N.E.C.
472NO ENGLISH
2/5/2025Arkana For Food Industries Co.

Giza

EGYPTSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
328USUAL NAME
473LABELING
+2 more
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About This Page

This page displays 50 FDA import refusal records from 13 countries. Records on this page involve violations including 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS), 27 (DRUG GMPS), 11 (UNSAFE COL) and 19 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 687 of 10,077 • Showing records 34,301-34,350 of 503,850 total