Import Refusal Records

503,850 FDA import refusal records

Country

Start Date

End Date

Date	Firm	Country	Product	Violations
6/6/2025	HERMES CHEMICAL COMPANY Secunderabad	INDIA	TOLNAFTATE (ANTI-FUNGAL) (NOT ANTIBIOTIC)	118NOT LISTED 2280DIRSEXMPT +1 more
6/6/2025	Kering Eyewear Spa Padova	ITALY	SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 341REGISTERED
6/6/2025	Luxottica Group S.P.A. AGORDO	ITALY	SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 341REGISTERED
6/6/2025	Kering Eyewear Spa Padova	ITALY	SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 341REGISTERED
6/6/2025	Luxottica Group S.P.A. AGORDO	ITALY	SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 341REGISTERED
6/6/2025	FISON TRADING Sialkot	PAKISTAN	SYRINGE, IRRIGATING (DENTAL)	118NOT LISTED 290DE IMP GMP +2 more
6/6/2025	Cipla Limited Mumbai	INDIA	TAMSULOSIN HCL (REGULATOR)	118NOT LISTED 75UNAPPROVED
6/6/2025	ABBOTT HEALTHCARE Mumbai	INDIA	IBUPROFEN (ANTI-INFLAMMATORY)	118NOT LISTED 75UNAPPROVED
6/6/2025	SANJIVAN ANUSANDHAM PVT LTD Haryana	INDIA	DIOHIPPURIC ACID I 125 (RADIOACTIVE AGENT)	118NOT LISTED 75UNAPPROVED
6/6/2025	PHARMTAK OPHTALMICS INDIA PVT LT Mumbai	INDIA	WATER, PURIFIED (EYEWASH)	118NOT LISTED 75UNAPPROVED
6/6/2025	SUN PHARMA Mumbai	INDIA	SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)	118NOT LISTED 75UNAPPROVED
6/6/2025	Eli Lilly & Company Indianapolis	UNITED STA	TIRZEPATIDE (ANTI-DIABETIC)	118NOT LISTED 75UNAPPROVED
6/6/2025	SUN PHARMACEUTICAL LABORATORIES Ranipool	INDIA	ANTI-DIABETIC N.E.C.	118NOT LISTED 75UNAPPROVED
6/6/2025	Pivdenagropererobka Myrne	UKRAINE	PEAS	83NO PROCESS
6/6/2025	Astrazeneca Colombia Sa Bogota	COLOMBIA	QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	CATALENT ARGENTINA S.A.I.C Unknown	ARGENTINA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	UNKNOWN UNKNOWN	COLOMBIA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
6/6/2025	Cardinal Agri Products, Inc. Brooke'S Point	PHILIPPINE	COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS	62NEEDS FCE 83NO PROCESS
6/6/2025	Cardinal Agri Products, Inc. Brooke'S Point	PHILIPPINE	COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS	62NEEDS FCE 83NO PROCESS
6/6/2025	Cardinal Agri Products, Inc. Brooke'S Point	PHILIPPINE	COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS	62NEEDS FCE 83NO PROCESS
6/6/2025	TARAMPS ELECTRONICS LTDA Sao Paulo	BRAZIL	GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL	47NON STD
6/6/2025	Song Tran Import and Export Co., Ltd Duc Hoa District	VIETNAM	EEL	9SALMONELLA
6/6/2025	UNION MEDICO APS Copenhagen	DENMARK	INTRODUCER, SYRINGE NEEDLE	39043904 39053905
6/6/2025	UNION MEDICO APS Copenhagen	DENMARK	INTRODUCER, SYRINGE NEEDLE	39043904 39053905
6/6/2025	UNION MEDICO APS Copenhagen	DENMARK	INTRODUCER, SYRINGE NEEDLE	39043904 39053905
6/6/2025	UNION MEDICO APS Copenhagen	DENMARK	INTRODUCER, SYRINGE NEEDLE	39043904 39053905
6/6/2025	UNION MEDICO APS Copenhagen	DENMARK	INTRODUCER, SYRINGE NEEDLE	39043904 39053905
6/6/2025	UNION MEDICO APS Copenhagen	DENMARK	INTRODUCER, SYRINGE NEEDLE	39043904 39053905
6/6/2025	UNION MEDICO APS Copenhagen	DENMARK	INTRODUCER, SYRINGE NEEDLE	39043904 39053905
6/6/2025	UNION MEDICO APS Copenhagen	DENMARK	INTRODUCER, SYRINGE NEEDLE	39043904
6/6/2025	MAE KHEM CO LTD Tak	THAILAND	BETEL NUT, IN SHELL	3878POISONORD
6/6/2025	ECLAT FOODZ LLP Navi Mumbai	INDIA	OTHER FRUITS, MIXED, JUICES OR CONCENTRATES	3864NCONTACT 482NUTRIT LBL
6/6/2025	ECLAT FOODZ LLP Navi Mumbai	INDIA	OTHER FRUITS, MIXED, JUICES OR CONCENTRATES	3864NCONTACT 482NUTRIT LBL
6/6/2025	Swedish Match Ab Stockholm	SWEDEN	NICOTINE DELIVERY PRODUCT, NEC	3854TPLKUSSLLB
6/6/2025	Swedish Match Ab Stockholm	SWEDEN	NICOTINE DELIVERY PRODUCT, NEC	3854TPLKUSSLLB
6/6/2025	Swedish Match Ab Stockholm	SWEDEN	NICOTINE DELIVERY PRODUCT, NEC	3854TPLKUSSLLB
6/6/2025	NGP TOBACCO Aalborg Sv	DENMARK	NICOTINE DELIVERY PRODUCT, NEC	3854TPLKUSSLLB

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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), 2280 (DIRSEXMPT), 3280 (FRNMFGREG), 341 (REGISTERED), 290 (DE IMP GMP) and 12 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

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