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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
10/29/2025Abbvie Corporation

Saint-Laurent

CANADACARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT
118NOT LISTED
3280FRNMFGREG
+1 more
10/29/2025Abbvie Corporation

Saint-Laurent

CANADACARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT
118NOT LISTED
3280FRNMFGREG
+1 more
10/29/2025Interojo Inc.

Pyeongtaek City

SOUTH KORELENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
3280FRNMFGREG
10/29/2025ALTRUAN GMBH

Massing

GERMANYGENERAL PURPOSE REAGENT
118NOT LISTED
3280FRNMFGREG
10/29/2025HONGMALL JAPAN CORP

Chikawa Chiba

JAPANLENS, CONTACT (DISPOSABLE)
118NOT LISTED
3280FRNMFGREG
10/29/2025Hugel Inc.

Chuncheon

SOUTH KOREONABOTULINUMTOXINA
118NOT LISTED
3260NO ENGLISH
+2 more
10/29/2025BR COSMETIC

Gangwon-Do 26348

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
2280DIRSEXMPT
+2 more
10/29/2025BR COSMETIC

Gangwon-Do

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
2280DIRSEXMPT
+2 more
10/29/2025GMP Medicare Sdn Bhd(F25)

Klang

MALAYSIAGLOVE, PATIENT EXAMINATION, POLY
118NOT LISTED
508NO 510(K)
10/29/2025Tricycle Ltd

Seoul

SOUTH KOREMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
476NO REGISTR
10/29/2025Tricycle Ltd

Seoul

SOUTH KOREMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
476NO REGISTR
10/29/2025FM MEIN ARZTBEDARF GMBH

Hall In Tirol

AUSTRIAGENERAL PURPOSE REAGENT
118NOT LISTED
237NO PMA
+2 more
10/29/2025Laboratoires Vivacy

Archamps

FRANCEOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
118NOT LISTED
237NO PMA
+2 more
10/29/2025DONGKOOK

Chungcheongbuk-Do

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
10/29/2025Kderma

Unknown

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+4 more
10/29/2025Exocobio, Inc.

Seoul

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+4 more
10/29/2025NerPharMa S.r.l.

Nerviano

ITALYDASATINIB
118NOT LISTED
75UNAPPROVED
10/29/2025BONIN

Sacatepequez

GUATEMALAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
10/29/2025MAVI FARMACEUTICA, S.A. DE C.V.

Ciudad De Mexico

MEXICOBENZYDAMINE HCL (ANALGESIC)
118NOT LISTED
75UNAPPROVED
10/29/2025PRODUCTOS MAVI S.A.DE C.V.

Ciudad De Mexico

MEXICOBENZYDAMINE HCL (ANALGESIC)
118NOT LISTED
75UNAPPROVED
10/29/2025LABORATORIOS BEST S.A. DE CV OL

Jalisco

MEXICODEXAMETHASONE ACETATE (GLUCOCORTICOID)
118NOT LISTED
75UNAPPROVED
10/29/2025SANOFI AVENTIS DE MEXICO SA CV

Mexico City

MEXICOINSULIN PURIFIED HUMAN SEMISYNTHETIC (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
10/29/2025Bruluagsa S.A. de C.V.

Atlacomulco

MEXICOINSULIN PURIFIED HUMAN SEMISYNTHETIC (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
10/29/2025Gandhar Oil Refinery (India) limited

Panvel

INDIASODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
10/29/2025Proteos Biotech SL

Albacete

SPAINCOLLAGENASE
75UNAPPROVED
10/29/2025GHANTA FOODS PVT LTD

Nandiwanaparthy

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
10/29/2025CATARINO MARTINEZ TOVAR

Ramos Arizpe

MEXICOJALAPENO PEPPER, HOT, DRIED OR PASTE
48NEEDS ACID
10/29/2025Bebidas Mundiales, S. de R.L. de C.V. (Planta Insurgentes)

Monterrey

MEXICOSOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED
11UNSAFE COL
274COLOR LBLG
10/29/2025bebidas mundiales,s.a de c.v.

Monterrey

MEXICOSOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025BARCEL, S.A. DE C.V

Pueblo Infonavit Lerma

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025Sabritas S. de R.L. de C.V. , Planta ABC

Ciudad De Mexico

MEXICOPOTATO CHIPS,FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCHEESE PUFFS, FIRED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCHEESE PUFFS, FIRED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/29/2025Purity Bakery

Nassau

BAHAMASCAKE WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
218LIST INGRE
+1 more
10/29/2025Shanghai Ziquan Beverage Industrial Co., LTD.

Shanghai

CHINATEA, GREEN
3898INADPRCCTL
62NEEDS FCE
10/29/2025Shanghai Ziquan Beverage Industrial Co., LTD.

Shanghai

CHINATEA, GREEN
3898INADPRCCTL
62NEEDS FCE
10/29/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
10/29/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
10/29/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB

About This Page

This page displays 50 FDA import refusal records from 15 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 75 (UNAPPROVED), 3260 (NO ENGLISH), 2280 (DIRSEXMPT) and 12 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 168 of 10,077 • Showing records 8,351-8,400 of 503,850 total