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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
1/31/2002Daiwha Corporation Ltd

Seoul

KENYAUNIT, ELECTROSURGICAL
118NOT LISTED
508NO 510(K)
1/31/2002Imasonic

Besancon

FRANCECAMERA, OPHTHALMIC, AC-POWERED
118NOT LISTED
508NO 510(K)
1/31/2002Mattes-Instrumente

Tuttlingen

GERMANYINSTRUMENT, MANUAL, GENERAL SURGICAL
118NOT LISTED
1/31/2002Apothecus Pharmaceutical Corp.

Hicksville

UNITED STANONOXYNOL 9 (SPERMATICIDE)
115DR QUALITY
118NOT LISTED
1/31/2002Aston Pharmacy

Kempton Park

SOUTH AFRIMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/31/2002Pro-Home Inc

Mexico

MEXICOHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
1/31/2002MDS Pharma Services

Saint-Laurent

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/31/2002Flying Cargo Bulgaria

Bourgas

BULGARIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/31/2002Flying Cargo Bulgaria

Bourgas

BULGARIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/31/2002Flying Cargo Bulgaria

Bourgas

BULGARIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/31/2002Ahmed M Elaidy

Cario

EGYPTMENOTROPINS (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
1/31/2002Ahmed M Elaidy

Cario

EGYPTFOLLISTIM (FOLLITROPIN BETA(RDNA)) (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
1/31/2002Adn Servicios Empresariales

Valencia

VENEZUELAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/31/2002Adn Servicios Empresariales

Valencia

VENEZUELASIBUTRAMINE HCL MONOHYDRATE (ANOREXIC)
75UNAPPROVED
1/31/2002Mediatronic S.A.

Les Acacias

SWITZERLANMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/31/2002MSH Pharma Inc.

Mont-Saint-Hilaire

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/31/2002Samwon Electronics Inc

Buchon City

SOUTH KORESOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE
47NON STD
1/31/2002Samwon Electronics Inc

Buchon City

SOUTH KORESOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE
47NON STD
1/31/2002Aiwa Latinoamerica (Panama), S.A.

Panama

PANAMASOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE
47NON STD
1/31/2002Aiwa Latinoamerica (Panama), S.A.

Panama

PANAMASOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE
47NON STD
1/31/2002Samwon Electronics Inc

Buchon City

SOUTH KORESOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE
47NON STD
1/31/2002Prof Hersh Chadha Lrps

Dubai

UNITED ARACD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
1/31/2002Federal Express Corpn

Selangor

MALAYSIAMISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
1/31/2002Rojiar (Rojar) Corp. (Manufacturing site)

Tehran

IRANMELON SEEDS (EDIBLE SEED)
11UNSAFE COL
1/31/2002Gepimex 404 Company

Cantho City

VIETNAMCLAMS
9SALMONELLA
1/31/2002Gepimex 404 Company

Cantho City

VIETNAMCLAMS
9SALMONELLA
1/30/2002Philips Respironics, Inc.

Murrysville

UNITED STAMONITOR (APNEA DETECTOR), VENTILATORY EFFORT
2780DEVICEGMPS
1/30/2002Addai

Den

NETHERLANDVITAMIN, N.E.C.
2300DIETARYLBL
1/30/2002Milan Trading Inc

Houston

UNITED STAORTHOPEDIC IMPLANT MATERIAL
508NO 510(K)
1/30/2002Mira Linder Spa in the City

Southfield

UNITED STAOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
471CSTIC LBLG
1/30/2002Mira Linder Spa in the City

Southfield

UNITED STAOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
471CSTIC LBLG
1/30/2002Basic Research Llc

Provo

UNITED STAOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
471CSTIC LBLG
1/30/2002Estrall Marketing

Manila

PHILIPPINEACID (LACTIC) CASEIN, SHEEP MILK
308MFR INSAN
62NEEDS FCE
+1 more
1/30/2002East Asia Co., Ltd

Hochiminh City

VIETNAMMILK, CONCENTRATED, EVAPORATED AND CONDENSED
308MFR INSAN
1/30/2002Agro Smak

Opatowek

POLANDALLSPICE, NATURAL EXTRACT OR FLAVOR (SPICE)
256INCONSPICU
1/30/2002Agro Smak

Opatowek

POLANDNATURAL EXTRACT OR FLAVOR, N.E.C.
256INCONSPICU
1/30/2002P.T. Tirta Raya Mina (Persero)

Jakarta

INDONESIATUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
249FILTHY
1/30/2002Yung Sung Industrial Co Ltd

Seoul

SOUTH KOREPEAR (CORE FRUIT)
241PESTICIDE
1/30/2002Earthworks Pottery

St.Thomas

BARBADOSPITCHERS (W/HANDLE, LIP SPOUT; AND W/O LID), (FOODWARE, COOKWARE & TABLEWARE)
238UNSAFE ADD
1/30/2002Earthworks Pottery

St.Thomas

BARBADOSBOWLS, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE)
238UNSAFE ADD
1/30/2002Earthworks Pottery

St.Thomas

BARBADOSCREAMERS, SMALL CONTAINERS W/HANDLE, W/LIP SPOUT AND W/O LID) (FOODWARE, COOKWARE & TABLEWARE)
238UNSAFE ADD
1/30/2002Agraimpex Sp. z o.o.

Warsaw

POLANDSTRAWBERRIES (BERRY)
238UNSAFE ADD
1/30/2002Biscuiterie Traou Mad

Pont Aven

FRANCEPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
1/30/2002Mediolast Spa

Milano

ITALYMISCELLANEOUS PATENT MEDICINES, ETC.
179AGR RX
1/30/2002Bina Dried Fruits Export Co.Ltd

Tehran

IRANRAISINS, DRIED OR PASTE
157FOREIGN OB
1/30/2002Ranjbar World Trading Co.

Tehran

IRANRAISINS, DRIED OR PASTE
157FOREIGN OB
1/30/2002Shanghai Foreign Service Co., Ltd

Shanghai

CHINASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
+1 more
1/30/2002Kairali Decan Merchandisers

Kerala

INDIASTANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
75UNAPPROVED
1/30/2002Surinam Air Cargo

Schiphol

NETHERLANDSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
118NOT LISTED
1/30/2002QLT Inc.

Vancouver

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
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About This Page

This page displays 50 FDA import refusal records from 25 countries. Records on this page involve violations including 118 (NOT LISTED), 508 (NO 510(K)), 115 (DR QUALITY), 75 (UNAPPROVED), 47 (NON STD) and 18 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 9968 of 10,038 • Showing records 498,351-498,400 of 501,854 total