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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/22/2025E-FILLERS SA

Athens

GREECEIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
1/22/2025Bora Pharmaceutical Services Inc.

Mississauga

CANADAPAROXETINE (ANTI-DEPRESSANT)
118NOT LISTED
75UNAPPROVED
1/22/2025Lilly del Caribe, Inc

Carolina

UNITED STAOLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II
118NOT LISTED
75UNAPPROVED
1/22/2025VICHY LABORATOIRE

Vichy

FRANCEIVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
118NOT LISTED
75UNAPPROVED
1/22/2025Laboratoires Galderma

Alby Sur Cheran

FRANCEIVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
118NOT LISTED
75UNAPPROVED
1/22/2025GRUPO CANTABRIA LABS

Madrid

SPAINHERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
1/22/2025Laboratoires Galderma

Alby Sur Cheran

FRANCEMETRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
118NOT LISTED
75UNAPPROVED
1/22/2025Procaps S.A.

Barranquilla

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
1/22/2025ENCOR HEALTHCARE PVT LTD

Aurangabad

INDIALOPERAMIDE (ANTI-PERISTALTIC)
118NOT LISTED
75UNAPPROVED
1/22/2025CIPLA LTD

Haridwar

INDIANORFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)
118NOT LISTED
75UNAPPROVED
1/22/2025AJANTA PHARMA LTD

Kamrup Assam

INDIAMETOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
75UNAPPROVED
1/22/2025IPR Pharmaceuticals, Inc.

Canovanas

UNITED STAROSUVASTATIN CALCIUM
118NOT LISTED
75UNAPPROVED
1/22/2025LIFECARE NEURO PVT LTD

PRADESH

INDIADIVALPROEX SODIUM (ANTI-CONVULSANT)
118NOT LISTED
75UNAPPROVED
1/22/2025Glenmark Pharmaceuticals Limited

Solan

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
27DRUG GMPS
+1 more
1/22/2025OBAGI RHOTO

Osaka

JAPANULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
1/22/2025Allkind Healthcare Unit-II

Solan

INDIAFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
1/22/2025NOVO NORDISK

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
1/22/2025Sejun Food Co., Ltd

Gwangju

SOUTH KOREBEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
62NEEDS FCE
83NO PROCESS
1/22/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
11UNSAFE COL
238UNSAFE ADD
+4 more
1/22/2025Stc India Pvt. Ltd.

Mumbai

INDIAMIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
11UNSAFE COL
218LIST INGRE
+2 more
1/22/2025Lekorna

M. Bohodukhiv

UKRAINEPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
11UNSAFE COL
218LIST INGRE
+5 more
1/22/2025Swaraj Techno Engg. Pvt. Ltd.

Haryana

INDIACUSTARD, REGULAR, VANILLA OR VANILLIN FLAVORED
11UNSAFE COL
218LIST INGRE
+3 more
1/22/2025Great Lakes Food Company Ltd

Chatham

CANADASMELT
9SALMONELLA
1/22/2025ALIBRAS ALIMENTOS BRASIL

Dom Cavati

BRAZILPEPPER, BLACK, GROUND, CRACKED (SPICE)
9SALMONELLA
1/22/2025Saigon Aquatic Products Trading Joint Stock Company Branch - Hung Thinh Frozen Food Factory

Ho Chi Minh

VIETNAMTILAPIA, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
9SALMONELLA
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENSMOKELESS TOBACCO POUCHES
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENSNUS
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENSNUS
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENSNUS
3854TPLKUSSLLB
1/22/2025Gn Tobacco Sweden Ab

Bispgarden

SWEDENSNUS
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/22/2025XQS INTERNATIONAL AB

Borlange

SWEDENSNUS
3854TPLKUSSLLB

About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 118 (NOT LISTED), 237 (NO PMA), 341 (REGISTERED), 75 (UNAPPROVED), 27 (DRUG GMPS) and 14 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 718 of 10,077 • Showing records 35,851-35,900 of 503,850 total