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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/17/2025Intas Pharmaceuticals Limited

Ahmedabad

INDIAAMISULPRIDE
75UNAPPROVED
1/17/2025DULAC FARMACEUTICI 1982 SRL

Turin

ITALYVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/17/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/17/2025Anhui Shanliren Foods Co, Ltd

Ningguo

CHINABEAN CURD, FRESH - SOFT OR HARD (MULTIPLE FOOD SPECIALTIES, SIDE DISHES AND DESSERTS)
62NEEDS FCE
83NO PROCESS
1/17/2025Sichuan Xiangxiangzui Food Co., Ltd.

Guangyuan

CHINABEAN CURD, FRESH - SOFT OR HARD (MULTIPLE FOOD SPECIALTIES, SIDE DISHES AND DESSERTS)
62NEEDS FCE
83NO PROCESS
1/17/2025Intas Pharmaceuticals Limited

Ahmedabad

INDIAGEMCITABINE HCL (ANTI-NEOPLASTIC)
27DRUG GMPS
1/17/2025CASA CUERVO

Ciudad De Mexico

MEXICOMIXED FRUIT, JUICES OR CONCENTRATES N.E.C.,
11UNSAFE COL
218LIST INGRE
+4 more
1/17/2025GRB DAIRY FOODS PVT LTD

Begepalli

INDIAMIXED STARCH SNACKS, BAKED
9SALMONELLA
1/16/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
1/16/2025XQS INTERNATIONAL AB

Borlange

SWEDENSNUS
3854TPLKUSSLLB
1/16/2025XQS INTERNATIONAL AB

Borlange

SWEDENSNUS
3854TPLKUSSLLB
1/16/2025Jiangsu Aimeili Cosmetic Co., Ltd.

Yangzhou

CHINAMETHYLBENZETHONIUM CHLORIDE (ANTI-INFECTIVE, TOPICAL)
3845DRG REF EI
1/16/2025YANGZHOU TRACEY DAILY CHEMICAL PLASTIC CO LTD

Yangzhou

CHINAMETHYLBENZETHONIUM CHLORIDE (ANTI-INFECTIVE, TOPICAL)
3845DRG REF EI
1/16/2025YANGZHOU TRACEY DAILY CHEMICAL PLASTIC CO LTD

Yangzhou

CHINAMETHYLBENZETHONIUM CHLORIDE (ANTI-INFECTIVE, TOPICAL)
3845DRG REF EI
1/16/2025Fiedler & Lundgren Ab

Malmo

SWEDENSNUS
3842TP NO PMTA
3843TP NO SE
1/16/2025Pt. Kelola Mina Laut- Integrated Seafood Industries

Gresik

INDONESIATUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
2360HISTAMINE
249FILTHY
1/16/2025Pt. Kelola Mina Laut- Integrated Seafood Industries

Gresik

INDONESIATUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
2360HISTAMINE
249FILTHY
1/16/2025Pt. Kelola Mina Laut- Integrated Seafood Industries

Gresik

INDONESIATUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
2360HISTAMINE
249FILTHY
1/16/2025ADISUTRA AYURVEDS LLP

Maharashtra

INDIAMINERAL N.E.C.
2300DIETARYLBL
321LACKS N/C
+2 more
1/16/2025VINAYAK PHARMA CHEM EQUIPMENT

Haridwar

INDIAFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
2280DIRSEXMPT
1/16/2025The Himalaya Drug Company

Nalagarh

INDIAPASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
2280DIRSEXMPT
1/16/2025Cupid Ltd.

Nashik

INDIACONDOM
477HOLES
508NO 510(K)
1/16/2025NEW STAR DENTAL LAB CO., LTD

Shenzhen

CHINARESTORATION, PORCELAIN
341REGISTERED
1/16/2025NEW STAR DENTAL LAB CO., LTD

Shenzhen

CHINADENTURES, PARTIAL
341REGISTERED
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
9SALMONELLA
1/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
1/16/2025QL FOODS SDN. BHD.

Hutan Melintang

MALAYSIAFISH CAKES, BALLS, ETC., N.E.C.
295LISTERIA
1/16/2025QL FOODS SDN. BHD.

Hutan Melintang

MALAYSIAFISH CAKES, BALLS, ETC., N.E.C.
295LISTERIA
1/16/2025QL FOODS SDN. BHD.

Hutan Melintang

MALAYSIAFISH CAKES, BALLS, ETC., N.E.C.
295LISTERIA
1/16/2025QL FOODS SDN. BHD.

Hutan Melintang

MALAYSIAFISH CAKES, BALLS, ETC., N.E.C.
295LISTERIA
1/16/2025QL FOODS SDN. BHD.

Hutan Melintang

MALAYSIAFISH CAKES, BALLS, ETC., N.E.C.
295LISTERIA
1/16/2025QL FOODS SDN. BHD.

Hutan Melintang

MALAYSIAFISH CAKES, BALLS, ETC., N.E.C.
295LISTERIA
1/16/2025QL FOODS SDN. BHD.

Hutan Melintang

MALAYSIAFISH CAKES, BALLS, ETC., N.E.C.
295LISTERIA
1/16/2025QL FOODS SDN. BHD.

Hutan Melintang

MALAYSIAFISH CAKES, BALLS, ETC., N.E.C.
295LISTERIA
1/16/2025QL FOODS SDN. BHD.

Hutan Melintang

MALAYSIAFISH CAKES, BALLS, ETC., N.E.C.
295LISTERIA
1/16/2025QL FOODS SDN. BHD.

Hutan Melintang

MALAYSIAFISH CAKES, BALLS, ETC., N.E.C.
295LISTERIA

About This Page

This page displays 50 FDA import refusal records from 8 countries. Records on this page involve violations including 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS), 27 (DRUG GMPS), 11 (UNSAFE COL) and 20 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 729 of 10,077 • Showing records 36,401-36,450 of 503,850 total