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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
3/25/2025Productos Maver, S.A. de C.V.

Tlaquepaque

MEXICOORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC)
75UNAPPROVED
3/25/2025PRODUCTOS FARMACEUTICOS COLLINSSA

Zapopan

MEXICOLORATADINE (ANTI-ASTHMATIC)
75UNAPPROVED
3/25/2025Sesderma, SL

Rafelbunol

SPAINFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
3/25/2025NEIMETH INTERNATIONAL PHARMACEUT

Ikeja

NIGERIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/25/2025Medreich Sterilab Ltd

Bangalore

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/25/2025ROYAL HERBAL HOME

Lagos

NIGERIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/25/2025Divya Pharmacy

Hardwar

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/25/2025RAVENBHEL BIOTECH

JAMMU

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/25/2025LEX MARK PHARMACUTICAL PVT LTD

Mehsana

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/25/2025Troikaa Pharmaceuticals Ltd

Ahmedabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/25/2025MICRO LABS LIMITED MAMRING

Namchi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/25/2025COTECH HEALTHCARE PVT LTD

Kishanpur

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/25/2025Intas Pharmaceuticals Limited

Moraiya

INDIAFLOXACILLIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
3/25/2025UNISON PHARMACEUTICALS

Gurugram

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/25/2025PLANTAS MEDICINALES LA GUADALUPA

Carranza

MEXICODIETARY CONVENTIONAL FOODS, N.E.C.
75UNAPPROVED
3/25/2025LABORATORIO ASPEN COLOMBIA SAS

Bogota

COLOMBIAZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN)
75UNAPPROVED
3/25/2025LABORATORIO HALEON COLOMBIA SAS

Bogota

COLOMBIATRIBENOSIDE (SCLEROSING AGENT)
75UNAPPROVED
3/25/2025RIDGE FORMULATIONS PVT LTD

Solan

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
3/25/2025RIDGE FORMULATIONS PVT LTD

Solan

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
3/25/2025JUGGAT PHARMA

KARNATAKA

INDIAANALGESIC, N.E.C.
75UNAPPROVED
3/25/2025Macleods Pharmaceuticals Limited

Daman

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
3/25/2025IPCA LABORATORIES LIMITED

BHARIKHOLA

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
3/25/2025Macleods Pharmaceuticals

Ranipool

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
3/25/2025Pure & Cure Healthcare Pvt Ltd

Uttarakhand

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
3/25/2025SUN PHARMA IND LTD

East Sikkim

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
3/25/2025Novartis De Colombia S.A

Bogota

COLOMBIADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
3/25/2025Pfizer

Bogota

COLOMBIAAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
3/25/2025Mehran Spice & Food Industries

Karachi

PAKISTANGARLIC BULB, DRIED OR PASTE
62NEEDS FCE
83NO PROCESS
3/25/2025Mehran Spice & Food Industries

Karachi

PAKISTANGARLIC BULB, DRIED OR PASTE
62NEEDS FCE
83NO PROCESS
3/25/2025CHAUGIAFOOD TRADING PRODUCTION CO.,LTD

Ho Chi Minh

VIETNAMBEAN CURD PASTE, (PACKAGE CONTAINS SEPARATE COMPONENTS REQUIRING MIXING AND/OR COOKING FOR PREP)
62NEEDS FCE
83NO PROCESS
3/25/2025CHAUGIAFOOD TRADING PRODUCTION CO.,LTD

Ho Chi Minh

VIETNAMBEAN CURD PASTE, (PACKAGE CONTAINS SEPARATE COMPONENTS REQUIRING MIXING AND/OR COOKING FOR PREP)
62NEEDS FCE
83NO PROCESS
3/25/2025Safe Harbor Hardware & Electronics

Shenzhen

CHINA3D LASER SCANNING SYSTEM
47NON STD
3/25/2025PREMIER DEAD SEA COSMETICS LABOR

Shoham

ISRAELLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
16DIRECTIONS
3/25/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
3/25/2025BARCEL, S.A. DE C.V

Pueblo Infonavit Lerma

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
3/25/2025BARCEL, S.A. DE C.V

Pueblo Infonavit Lerma

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
3/25/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
3/25/2025Suzhou renren jia food co.,ltd

Suzhou

CHINAMELON SEEDS (EDIBLE SEED)
11UNSAFE COL
274COLOR LBLG
3/25/2025Industrial Pastelera San Narciso, S.A. (Inpanasa)

Aiguaviva

SPAINBUTTER/BUTTER FLAVORED,COOKIE,BISCUIT,WAFER DOUGH
11UNSAFE COL
238UNSAFE ADD
3/25/2025Guangdong Hongyuan Food Co.,Ltd

Chaozhou

CHINACANDY WITHOUT CHOCOLATE N.E.C.
11UNSAFE COL
218LIST INGRE
+7 more
3/25/2025Zenith Drinks Pvt.Ltd.

New Delhi

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
3/25/2025Zenith Drinks Pvt.Ltd.

New Delhi

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
3/25/2025Zenith Drinks Pvt.Ltd.

New Delhi

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
3/25/2025Bikaji Foods International Ltd.

Bikaner

INDIAFRIED SNACK FOODS, N.E.C.
9SALMONELLA
3/25/2025PT. TRITUNGGAL LINTAS BENUA

Bekasi

INDONESIATUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
9SALMONELLA
3/25/2025THAITAN FOODS INTERNATIONAL

Photharam

THAILANDSUTROPICAL AND TROPICAL FRUIT, JUICE, MILK, CREME, DRINK OR NECTAR, N.E.C.
3886FSVP VIO
3/25/2025THAITAN FOODS INTERNATIONAL

Photharam

THAILANDPASSION FRUIT, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
3886FSVP VIO
3/25/2025THAITAN FOODS INTERNATIONAL

Photharam

THAILANDGUAVA, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
3886FSVP VIO
3/25/2025THAITAN FOODS INTERNATIONAL

Photharam

THAILANDLYCHEE, LICHEE, LITCHI, LEECHEE, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
3886FSVP VIO
3/25/2025THAITAN FOODS INTERNATIONAL

Photharam

THAILANDCOCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS
3886FSVP VIO

About This Page

This page displays 50 FDA import refusal records from 11 countries. Records on this page involve violations including 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS), 47 (NON STD), 16 (DIRECTIONS) and 12 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 615 of 10,077 • Showing records 30,701-30,750 of 503,850 total