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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
8/11/2025Sarvotham Care Ltd

Solan

INDIASTANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
3280FRNMFGREG
8/11/2025Arrow

Lyon

FRANCEAMISULPRIDE
118NOT LISTED
75UNAPPROVED
8/11/2025Lab Biogaran

Colombes

FRANCESERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
118NOT LISTED
75UNAPPROVED
8/11/2025Arrow

Lyon

FRANCESERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
118NOT LISTED
75UNAPPROVED
8/11/2025YANCHENG DILING MEDICAL INSTRUME

Jiangsu

CHINACANNULA, CATHETER
118NOT LISTED
16DIRECTIONS
+5 more
8/11/2025P.T. Nipro Indonesia Jaya

Karawang

INDONESIASET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
118NOT LISTED
8/11/2025P.T. Nipro Indonesia Jaya

Karawang

INDONESIASET, DIALYSIS, SINGLE NEEDLE WITH UNI-DIRECTIONAL PUMP
118NOT LISTED
8/11/2025Labomar Canada Inc

Pointe-Claire

CANADAWRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
118NOT LISTED
8/11/2025YUMNATURALS

Minden

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/11/2025YUMNATURALS

Minden

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/11/2025Pekana Naturheilmittel GmbH

Kislegg

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/11/2025Pharmazeutische Fabrik Dr. Reckeweg & Co. GmbH

Bensheim

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/11/2025NOVARTIS HEALTHCARE PVT LTD

Mumbai

INDIAINHIBITOR N.E.C.
75UNAPPROVED
8/11/2025LUPIN LTD

Sikkim

INDIAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
8/11/2025EYSYS PHARMACEUTICALS PVT LTD

Chennai

INDIASITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)
75UNAPPROVED
8/11/2025SUN PHARMA LABORATORIES LTD

Assam

INDIADAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
8/11/2025LIVIDUS PHARMACEUTICALS PVT LTD

Chennai

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
8/11/2025Blue Cross Laboratories

Nashik

INDIAGLIMEPIRIDE (ANTI-DIABETIC)
75UNAPPROVED
8/11/2025Mdc Pharmaceuticals Ltd

Baddi

INDIAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
8/11/2025REMIDEX PHARMA P LTD

Bangalore

INDIAASPIRIN (ANALGESIC)
75UNAPPROVED
8/11/2025Influx Healthtech Limited

Kolgaon

INDIAEMOLLIENT, LUBRICANT, N.E.C.
75UNAPPROVED
8/11/2025LYKA LABS LIMITED

Ankleshwar

INDIAANTI-RHEUMATIC N.E.C.
75UNAPPROVED
8/11/2025ESSENTIA PHARMA

Palhoca

BRAZILESTRADIOL (ESTROGEN)
75UNAPPROVED
8/11/2025ESSENTIA PHARMA

Palhoca

BRAZILDEHYDROEPIANDROSTERONE (ANDROGEN)
75UNAPPROVED
8/11/2025ESSENTIA PHARMA

Palhoca

BRAZILHYDROCORTISONE (GLUCOCORTICOID)
75UNAPPROVED
8/11/2025ESSENTIA PHARMA

Palhoca

BRAZILPROGESTERONE (PROGESTIN)
75UNAPPROVED
8/11/2025ESSENTIA PHARMA

Palhoca

BRAZILVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
8/11/2025ESSENTIA PHARMA

Palhoca

BRAZILLEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
8/11/2025CALZADA DEL HUESO

Ciudad De Mexico

MEXICOSERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
8/11/2025MESOSYSTEM S.A.

Lisbon

PORTUGALFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
8/11/2025Aurobindo Pharma USA Inc

East Windsor

UNITED STAROSUVASTATIN CALCIUM
75UNAPPROVED
8/11/2025A.G.BARR plc

Glasgow

UNITED KINSOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED
11UNSAFE COL
321LACKS N/C
+1 more
8/11/2025A.G.BARR plc

Glasgow

UNITED KINSOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED
11UNSAFE COL
321LACKS N/C
+1 more
8/11/2025Diana Candy Company Limited

Arima

TRINIDAD AHARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
8/11/2025Diana Candy Company Limited

Arima

TRINIDAD ACANDY WITHOUT CHOCOLATE N.E.C.
11UNSAFE COL
274COLOR LBLG
8/11/2025Diana Candy Company Limited

Arima

TRINIDAD AHARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
8/11/2025Diana Candy Company Limited

Arima

TRINIDAD ACANDY WITHOUT CHOCOLATE N.E.C.
11UNSAFE COL
274COLOR LBLG
8/11/2025BARCEL, S.A. DE C.V

Pueblo Infonavit Lerma

MEXICOPOTATO CHIPS,FRIED
11UNSAFE COL
274COLOR LBLG
8/11/2025BARCEL, S.A. DE C.V

Pueblo Infonavit Lerma

MEXICOPOTATO CHIPS,FRIED
11UNSAFE COL
274COLOR LBLG
8/11/2025BARCEL, S.A. DE C.V

Pueblo Infonavit Lerma

MEXICOPOTATO CHIPS,FRIED
11UNSAFE COL
274COLOR LBLG
8/11/2025Sabritas, S. De R.L. De C.V.

D.F.

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
8/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
8/8/2025QUALITY SPICES & FOOD EXPORTS PVT.LTD.

Ambernath (E)

INDIAANISE (STAR ANISE) (SPICE)
9SALMONELLA
8/8/2025CBI SRO

Teplice

CZECH REPUNICOTINE DELIVERY PRODUCT, NEC
3520TP FLAVOR
3842TP NO PMTA
+1 more
8/8/2025CBI SRO

Teplice

CZECH REPUNICOTINE DELIVERY PRODUCT, NEC
3520TP FLAVOR
3842TP NO PMTA
+1 more
8/8/2025PREMIUM POUCH FINLAND OY

Helsinki

FINLANDNICOTINE DELIVERY PRODUCT, NEC
3520TP FLAVOR
3842TP NO PMTA
+1 more
8/8/2025MICROZERO AB

Goteborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3520TP FLAVOR
3842TP NO PMTA
+1 more
8/8/2025MICROZERO AB

Goteborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3520TP FLAVOR
3842TP NO PMTA
+1 more
8/8/2025MICROZERO AB

Goteborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3520TP FLAVOR
3842TP NO PMTA
+1 more
8/8/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3520TP FLAVOR
3842TP NO PMTA
+1 more
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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), 16 (DIRECTIONS), 333 (LACKS FIRM) and 11 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 354 of 10,077 • Showing records 17,651-17,700 of 503,850 total