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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/27/2025KAHLU ORTHEPEDIC

Sialkot

PAKISTANSCREW, FIXATION, BONE
118NOT LISTED
3280FRNMFGREG
+2 more
1/27/2025HONG KONG ZOEY TRADING CO.,LIMITED

Hong Kong

HONG KONGMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
1/27/2025HONG KONG ZOEY TRADING CO.,LIMITED

Hong Kong

HONG KONGMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
1/27/2025HONG KONG ZOEY TRADING CO.,LIMITED

Hong Kong

HONG KONGMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
1/27/2025HONG KONG ZOEY TRADING CO.,LIMITED

Hong Kong

HONG KONGMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
1/27/2025HONG KONG ZOEY TRADING CO.,LIMITED

Hong Kong

HONG KONGMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
1/27/2025HONG KONG ZOEY TRADING CO.,LIMITED

Hong Kong

HONG KONGMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
1/27/2025DELTASPHARMA INDIA PRIVATE LIMITED

Haridwar

INDIAHOLY BASIL (HERBAL & BOTANICALS, NOT TEAS II)
118NOT LISTED
3280FRNMFGREG
+1 more
1/27/2025Dey'S Medical Stores Ltd

Kolkata

INDIAWATER, PURIFIED (EYEWASH)
118NOT LISTED
3280FRNMFGREG
+1 more
1/27/2025Sun Pharma Sikkim

East Sikkim

INDIALEVODOPA (ANTI-PARKINSONIAN)
118NOT LISTED
3280FRNMFGREG
+1 more
1/27/2025Anika Therapeutics, Inc.

Bedford

UNITED STAANTI-INFLAMMATORY N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
1/27/2025E.B. Beharry And Company Ltd

Georgetown

GUYANAMENTHOL (ANTI-PRURITIC)
118NOT LISTED
3280FRNMFGREG
1/27/2025SHENZHEN SHENG HUA INDUSTRIA LTD

Shenzhen

CHINAMASSAGER, THERAPEUTIC, MANUAL
118NOT LISTED
3280FRNMFGREG
1/27/2025SHENZHEN SHENGBANGHUA TECHNOLOGY

Shenzhen

CHINABRUSH, DERMABRASION
118NOT LISTED
508NO 510(K)
1/27/2025Mylan Laboratories Limited

Sarigam

INDIALEVONORGESTREL (ESTROGEN)
118NOT LISTED
75UNAPPROVED
1/27/2025Eskay Therapeutics

Acora

GHANAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
118NOT LISTED
75UNAPPROVED
1/27/2025SCHERING DO BRASIL LTDA

Sao Paulo

BRAZILMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
1/27/2025SHEIN FULFILLMENT

Zhaoqing

CHINARING, TEETHING, FLUID-FILLED
118NOT LISTED
1/27/2025Dongguan Kepler Special Cabling Company Limited

Dongguan

CHINACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
118NOT LISTED
1/27/2025SANDRA ARANGO

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/27/2025SANDRA ARANGO

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/27/2025SANDRA ARANGO

Bogota

COLOMBIAVANCOMYCIN HYDROCHLORIDE
75UNAPPROVED
1/27/2025CARR PICACHO AJUSCO

Ciudad De Mexico

MEXICOESTROGEN N.E.C.
75UNAPPROVED
1/27/2025LABORATOIRES BAILLEUL

Luxemburg

LUXEMBOURGTRETINOIN (KERATOLYTIC)
75UNAPPROVED
1/27/2025Pfizer Canada

Kirkland

CANADAANTIMIGRAINE, NEC
75UNAPPROVED
1/27/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINETOMATO SAUCE (WITH OTHER INGREDIENTS)
11UNSAFE COL
274COLOR LBLG
1/27/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
11UNSAFE COL
238UNSAFE ADD
+4 more
1/27/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
11UNSAFE COL
238UNSAFE ADD
+4 more
1/27/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
11UNSAFE COL
238UNSAFE ADD
+4 more
1/27/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
11UNSAFE COL
238UNSAFE ADD
+4 more
1/27/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
11UNSAFE COL
238UNSAFE ADD
+4 more
1/27/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
11UNSAFE COL
238UNSAFE ADD
+4 more
1/27/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
11UNSAFE COL
238UNSAFE ADD
+4 more
1/27/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
11UNSAFE COL
238UNSAFE ADD
+4 more
1/24/2025Sanofi Aventis De Colombia S.A.

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025PHARMETIQUE SA

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025GENOMMA LAB

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025NOVAMED LABS

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025Fuxion Biotech S.A.C.

Lurin

PERUMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025Laboratorios Ecar Ltda

Medellin

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025Laboratorios Laproff S.A.

Sabaneta

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025LABORATORIO GENFAR

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025VITALLIS

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025Laboratorios Ecar Ltda

Medellin

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025LABINCO S.A.

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025Pharmetique S A

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025COASPHARMA

Atlantico

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025TECNOQUIMICAS S A

Cali

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025LABORATORY SEA NATURAL

Santander

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025LICOL SAS

Antioquia

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
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About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 341 (REGISTERED), 508 (NO 510(K)), 75 (UNAPPROVED) and 6 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 707 of 10,077 • Showing records 35,301-35,350 of 503,850 total