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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
3/20/2025NEPTUNE LIFE SCIENCES PVT LTD

Thana Baddi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
3/20/2025Cipla Ltd

Dabhel Damandabhel Daman

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
3/20/2025NEPTUNE LIFE SCIENCES PVT LTD

Thana Baddi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
3/20/2025CIPLA LIMITED

Mumbai

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
3/20/2025SERVIER INDIA PRIVATE LTD

Aurangabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
3/20/2025Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)

Daman

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
3/20/2025GUPTA EXIM (INDIA) PVT

Haryana

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
3/20/2025Dr. Willmar Schwabe India Pvt. Ltd.

Sikandrabad

INDIAHOMEOPATHIC N.E.C.
118NOT LISTED
75UNAPPROVED
3/20/2025Dr. Willmar Schwabe India Pvt. Ltd.

Sikandrabad

INDIAHOMEOPATHIC GASTROINTESTINAL
118NOT LISTED
75UNAPPROVED
3/20/2025Dr. Willmar Schwabe India Pvt. Ltd.

Sikandrabad

INDIAHOMEOPATHIC RESPIRATORY
118NOT LISTED
75UNAPPROVED
3/20/2025DR RECKEWEG & CO

Bensheim

GERMANYHOMEOPATHIC RESPIRATORY
118NOT LISTED
75UNAPPROVED
3/20/2025DR RECKEWEG & CO

Bensheim

GERMANYHOMEOPATHIC RESPIRATORY
118NOT LISTED
75UNAPPROVED
3/20/2025DR RECKEWEG & CO

Bensheim

GERMANYHOMEOPATHIC ALLERGY
118NOT LISTED
75UNAPPROVED
3/20/2025DR RECKEWEG & CO

Bensheim

GERMANYHOMEOPATHIC N.E.C.
118NOT LISTED
75UNAPPROVED
3/20/2025DR RECKEWEG & CO

Bensheim

GERMANYHOMEOPATHIC RESPIRATORY
118NOT LISTED
75UNAPPROVED
3/20/2025Bora Pharmaceutical Services Inc.

Mississauga

CANADALIDOCAINE
118NOT LISTED
75UNAPPROVED
3/20/2025ALAHLAM CO. FOR FOOD PRODUCTS

Damascus Suburb

SYRIATRUFFLE, FUNGI PRODUCTS, N.E.C.
83NO PROCESS
3/20/2025RAFAEL ALBERTO ALOSO MORTALES

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
3/20/2025Janssen Inc.

North York

CANADAGUSELKUMAB
75UNAPPROVED
3/20/2025DH EQUISPORT

Maasmechelen

BELGIUMANIMAL BY-PRODUCTS AND EXTRACTS, N.E.C.
75UNAPPROVED
3/20/2025MARXX PHARMA

Rohtak

INDIAMOXIFLOXACIN HCL (FLUOROQUINOLONE)
75UNAPPROVED
3/20/2025MEDIVANTIS LIFESCIENCE PVT

Haryana

INDIAVITAMIN, N.E.C.
75UNAPPROVED
3/20/2025HILLSON HEALTH CARE

Unijan

INDIAVITAMIN, N.E.C.
75UNAPPROVED
3/20/2025Amgen Labpoint

Newbury Park

UNITED STAERENUMAB-AOOE
75UNAPPROVED
3/20/2025Intas Pharmaceuticals Limited

Ahmedabad

INDIAANTI-ECZEMATIC N.E.C.
27DRUG GMPS
3/20/2025Hazer Baba Gida Sanayi Ic ve Dis Tic. Ltd. Sti.

Sancaktepe

TURKEYSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
3/20/2025Suncrest Foods Incorporated

Metro Manila

PHILIPPINEBISCUITS
11UNSAFE COL
274COLOR LBLG
3/20/2025PALM BITES

Mississauga

CANADACHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)
9SALMONELLA
3/20/2025PALM BITES

Mississauga

CANADACHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)
9SALMONELLA
3/19/2025NINGBO BAICHEN MEDICAL DEVICES CO., LTD

Ningbo

CHINAWHEELCHAIR, POWERED
39043904
39053905
+1 more
3/19/2025MEDITIME CO., LTD

Wonju

SOUTH KORESUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
39043904
39053905
3/19/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
3/19/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
3/19/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
3/19/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
3/19/2025Luna Corporate

Suchy Las

POLANDNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
3/19/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3781TPNOWRNLBL
3842TP NO PMTA
+3 more
3/19/2025GOFARM SP ZOO SP.K

Cracow

POLANDMISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
3/19/2025OH MY COSMETICS CO LTD

Gyeonggi Do

SOUTH KOREMOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
3/19/2025K. KARAGEORGIOU BROS

Athens

GREECERICE, PLAIN (WHITE OR POLISHED) PROCESSED (PACKAGED)
321LACKS N/C
324NO ENGLISH
+2 more
3/19/2025SHANDONG SEAMAN MACHINEERY CO LT

Jinan

CHINALASER MARKER OR ENGRAVER
278NO TAG
47NON STD
3/19/2025Gwalia Sweets Pvt Ltd

Ahmedabad

INDIAMULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
274COLOR LBLG
3/19/2025Gwalia Sweets Pvt Ltd

Ahmedabad

INDIAMULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
274COLOR LBLG
3/19/2025Gwalia Sweets Pvt Ltd

Ahmedabad

INDIAFLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
274COLOR LBLG
3/19/2025Gwalia Sweets Pvt Ltd

Ahmedabad

INDIAFLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
274COLOR LBLG
3/19/2025Carsibasi Sut Mamuller ve Sekerleme San Tic LTD

Melikgazi

TURKEYSOFT CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE)
274COLOR LBLG
3/19/2025Carsibasi Sut Mamuller ve Sekerleme San Tic LTD

Melikgazi

TURKEYFLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
274COLOR LBLG
3/19/2025Sri Varu Impex and Logistics

Chennai

INDIACAPSICUMS (CAYENNE CHILI, HOT PEPPERS), WHOLE (SPICE)
249FILTHY
320LACKS FIRM
+1 more
3/19/2025CHUPALETAS S.A DE C.V

San Pedro Tlaquepaque

MEXICOTAMARIND, DRIED OR PASTE
249FILTHY
3/19/2025Laxmi Enterprises

Navi Mumbai

INDIACAPSICUMS (CAYENNE CHILI, HOT PEPPERS), WHOLE (SPICE)
249FILTHY

About This Page

This page displays 50 FDA import refusal records from 15 countries. Records on this page involve violations including 118 (NOT LISTED), 75 (UNAPPROVED), 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 627 of 10,077 • Showing records 31,301-31,350 of 503,850 total