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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
9/4/2025ACME GENERICS LLP

Mumbai

INDIADEXTROTHYROXINE SODIUM (ANTI-CHOLESTEREMIC)
118NOT LISTED
75UNAPPROVED
9/4/2025BLUE CROSS LABORATORY PVT LTD

Ambad

INDIAPIOGLITAZONE HCL
118NOT LISTED
75UNAPPROVED
9/4/2025Eurofarma Laboratorios S.A.

Itapevi

BRAZILSERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
118NOT LISTED
75UNAPPROVED
9/4/2025Eurofarma Laboratorios S.A.

Itapevi

BRAZILLOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
75UNAPPROVED
9/4/2025Aspen Farmaceutica S/A

Sao Paulo

BRAZILTRAZODONE HCL (ANTI-DEPRESSANT)
118NOT LISTED
75UNAPPROVED
9/4/2025Quinfica Nutramedics Boldo

Guatemala

GUATEMALAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
9/4/2025FARMACIA FAMILIAR

Guatemala City

GUATEMALAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
9/4/2025Sanofi Winthrop Industrie

Val De Reuil

FRANCEEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
71NO LICENSE
+1 more
9/4/2025PARMALAT

Collecchio

ITALYOTHER FRUITS AND FRUIT PRODUCTS, OTHER FRUIT JUICES OR CONCENTRATES, N.E.C.
83NO PROCESS
9/4/2025PARMALAT

Collecchio

ITALYOTHER FRUITS AND FRUIT PRODUCTS, OTHER FRUIT JUICES OR CONCENTRATES, N.E.C.
83NO PROCESS
9/4/2025PARMALAT

Collecchio

ITALYOTHER FRUITS AND FRUIT PRODUCTS, OTHER FRUIT JUICES OR CONCENTRATES, N.E.C.
83NO PROCESS
9/4/2025PARMALAT

Collecchio

ITALYOTHER FRUITS AND FRUIT PRODUCTS, OTHER FRUIT JUICES OR CONCENTRATES, N.E.C.
83NO PROCESS
9/4/2025PARMALAT

Collecchio

ITALYAPPLE, CORE FRUIT JUICES OR CONCENTRATES
83NO PROCESS
9/4/2025BC LTD C/O PASTURE

Singapore

SINGAPOREAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
9/4/2025BHAVANI YOGESH SHAMBHUBHA

Thiruvananthapuram

INDIAMELOXICAM (ANTI-INFLAMMATORY, PART II)
75UNAPPROVED
9/4/2025BHAVANI YOGESH SHAMBHUBHA

Thiruvananthapuram

INDIAIVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
75UNAPPROVED
9/4/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
9/4/2025Mesosystems Sa

Porto

PORTUGALFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
9/4/2025Mesosystems Sa

Porto

PORTUGALFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
9/4/2025Mesosystems Sa

Porto

PORTUGALFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
9/4/2025Mesosystems Sa

Porto

PORTUGALFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
9/4/2025Reckitt Benckiser

Mysore

INDIADISINFECTANT N.E.C.
75UNAPPROVED
9/4/2025Sabritas S. de R.L. de C.V. Planta Saltillo

Saltillo

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
+1 more
9/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOFRIED SNACK FOODS, N.E.C.
11UNSAFE COL
274COLOR LBLG
9/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOFRIED SNACK FOODS, N.E.C.
11UNSAFE COL
274COLOR LBLG
9/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOFRIED SNACK FOODS, N.E.C.
11UNSAFE COL
274COLOR LBLG
9/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOFRIED SNACK FOODS, N.E.C.
11UNSAFE COL
274COLOR LBLG
9/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, BAKED
11UNSAFE COL
274COLOR LBLG
9/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, BAKED
11UNSAFE COL
274COLOR LBLG
9/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOWHEAT GRAIN SNACK (WHOLE, CRACKED, SPLIT), FRIED/OIL COOKED
11UNSAFE COL
274COLOR LBLG
9/4/2025BEYOGLU CIKOLATA SANAYI TICARET ANONIM SIRKETI

KILIS

TURKEYMIXED OR ASSORTED CHOCOLATE CANDIES (BARS, BOXES, LOOSE FORM), WITH NUTS OR NUT PRODUCTS (NOT COCONU
11UNSAFE COL
218LIST INGRE
+4 more
9/4/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+3 more
9/4/2025ZENITH DRINKS PVT LTD

New Delhi

INDIAFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
11UNSAFE COL
75UNAPPROVED
9/4/2025Swizzels Matlow Limited

High Peak

UNITED KINCANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
9/4/2025Swizzels Matlow Limited

High Peak

UNITED KINSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
9/4/2025Swizzels Matlow Limited

High Peak

UNITED KINSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
9/4/2025Swizzels Matlow Limited

High Peak

UNITED KINSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
9/4/2025ISHA LIFE PRIVATE LIMITED

Coimbatore

INDIABEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
9SALMONELLA
9/4/2025ISHA LIFE PRIVATE LIMITED

Coimbatore

INDIABEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
9SALMONELLA
9/4/2025ISHA LIFE PRIVATE LIMITED

Coimbatore

INDIABEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
9SALMONELLA
9/4/2025ISHA LIFE PRIVATE LIMITED

Coimbatore

INDIABEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
9SALMONELLA
9/4/2025ISHA LIFE PRIVATE LIMITED

Coimbatore

INDIABEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
9SALMONELLA
9/4/2025ISHA LIFE PRIVATE LIMITED

Coimbatore

INDIABEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
9SALMONELLA
9/4/2025ISHA LIFE PRIVATE LIMITED

Coimbatore

INDIABEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
9SALMONELLA
9/4/2025ISHA LIFE PRIVATE LIMITED

Coimbatore

INDIABEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
9SALMONELLA
9/4/2025A.L. Manufacture and Marketing Spices LTD

Be'Er Sheva

ISRAELPEPPER, BLACK, GROUND, CRACKED (SPICE)
9SALMONELLA
9/4/2025A.L. Manufacture and Marketing Spices LTD

Be'Er Sheva

ISRAELPEPPER, BLACK, GROUND, CRACKED (SPICE)
9SALMONELLA
9/4/2025YOIK AB

Gemla

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/4/2025MICROZERO AB

Goteborg

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
9/4/2025MICROZERO AB

Goteborg

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
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About This Page

This page displays 50 FDA import refusal records from 13 countries. Records on this page involve violations including 118 (NOT LISTED), 75 (UNAPPROVED), 71 (NO LICENSE), 83 (NO PROCESS), 11 (UNSAFE COL) and 11 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 294 of 10,077 • Showing records 14,651-14,700 of 503,850 total