Refusal Details As Recorded in OASIS by FDA

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal HK1-0200524-4/1/3

Manufacturer FEI / 3007289494
Manufacturer Name / ZHENJIANG NEW SELECT FOODS CO.,LTD
Manufacturer Address line 1 / No 8 Weiyilu
Manufacturer Address line 2 / DINGMAO DEVELOPMENT AREA
Manufacturer's City / Zh¿njiangsh¿
Manufacturer Province/State / Jiangsusheng
Manufacturer Country/Area / China
Product Code / 05YGT99
Importer's Product Description / GRANOLA APPLE & CINNAMON FLAVOR
Refusal Date / 06-Feb-2012
FDA District / LOS-DO
Entry/doc/line/sfx / HK1-0200524-4/1/3
FDA Sample Analysis / Yes
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
FILTHY / 402(a)(3), 801(a)(3); ADULTERATION / The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal HK1-0200524-4/1/2

Manufacturer FEI / 3007289494
Manufacturer Name / ZHENJIANG NEW SELECT FOODS CO.,LTD
Manufacturer Address line 1 / No 8 Weiyilu
Manufacturer Address line 2 / DINGMAO DEVELOPMENT AREA
Manufacturer's City / Zh¿njiangsh¿
Manufacturer Province/State / Jiangsusheng
Manufacturer Country/Area / China
Product Code / 05YGT99
Importer's Product Description / GRANOLA STRAWBERRY & KIWI FLAVOR
Refusal Date / 06-Feb-2012
FDA District / LOS-DO
Entry/doc/line/sfx / HK1-0200524-4/1/2
FDA Sample Analysis / Yes
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
FILTHY / 402(a)(3), 801(a)(3); ADULTERATION / The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal HK1-0200524-4/1/1

Manufacturer FEI / 3007289494
Manufacturer Name / ZHENJIANG NEW SELECT FOODS CO.,LTD
Manufacturer Address line 1 / No 8 Weiyilu
Manufacturer Address line 2 / DINGMAO DEVELOPMENT AREA
Manufacturer's City / Zh¿njiangsh¿
Manufacturer Province/State / Jiangsusheng
Manufacturer Country/Area / China
Product Code / 05YGT99
Importer's Product Description / GRANOLA BANANA & RAISINS
Refusal Date / 17-Feb-2012
FDA District / LOS-DO
Entry/doc/line/sfx / HK1-0200524-4/1/1
FDA Sample Analysis / Yes
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
FILTHY / 402(a)(3), 801(a)(3); ADULTERATION / The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal DK3-0752390-4/1/1

Manufacturer FEI / 2000006713
Manufacturer Name / jiangsu jiushoutang trade Co., Ltd
Manufacturer Address line 1 / tongji road xinghua city jiangsu china
Manufacturer Address line 2 / tongji road xinghua city jiangsu china
Manufacturer's City / xinghua
Manufacturer Province/State / CN-32
Manufacturer Country/Area / China
Product Code / 16AGD10
Importer's Product Description / FROZEN FARM RAISED CATFISH FILLETS
Refusal Date / 13-Feb-2012
FDA District / SWI-DO
Entry/doc/line/sfx / DK3-0752390-4/1/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / Yes
Charge(s) / Violation Code / Section / Charge Statement
UNSAFE ADD / 402(a)(2)(C)(i), 801(a)(3); ADULTERATION / The article appears to bear or contain a food additive which is unsafe within the meaning of Section 409. Contains
VETDRUGRES / 402(a)(2)(C)(ii); 801(a)(3); ADULTERATION / The article appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512. Product contains

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal MC2-6293279-1/1/1

Manufacturer FEI / 2000006713
Manufacturer Name / jiangsu jiushoutang trade Co., Ltd
Manufacturer Address line 1 / tongji road xinghua city jiangsu china
Manufacturer Address line 2 / tongji road xinghua city jiangsu china
Manufacturer's City / xinghua
Manufacturer Province/State / CN-32
Manufacturer Country/Area / China
Product Code / 16AGT10
Importer's Product Description / FROZEN CATFISH FILLETS
Refusal Date / 15-Feb-2012
FDA District / CHI-DO
Entry/doc/line/sfx / MC2-6293279-1/1/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / Yes
Charge(s) / Violation Code / Section / Charge Statement
UNSAFE ADD / 402(a)(2)(C)(i), 801(a)(3); ADULTERATION / The article appears to bear or contain a food additive which is unsafe within the meaning of Section 409. Contains
VETDRUGRES / 402(a)(2)(C)(ii); 801(a)(3); ADULTERATION / The article appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512. Product contains

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal G40-0245746-8/1/1

Manufacturer FEI / 3006454956
Manufacturer Name / Jiangsu HaiTian Sea-Beach Aquatic Foods Co., Ltd.
Manufacturer Address line 1 / North Qianjing Rd., JianggangTown,
Manufacturer Address line 2 / Dongtai, Yancheng, China.
Manufacturer's City / Dongtai
Manufacturer Province/State / CN-32
Manufacturer Country/Area / China
Product Code / 16XGD02
Importer's Product Description / FROZEN FARM RAISED CHANNEL CATFISH FILLETS, IQF;5-7OZ
Refusal Date / 28-Feb-2012
FDA District / SWI-DO
Entry/doc/line/sfx / G40-0245746-8/1/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / Yes
Charge(s) / Violation Code / Section / Charge Statement
VETDRUGRES / 402(a)(2)(C)(ii); 801(a)(3); ADULTERATION / The article appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512. Product contains

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal TZ6-0116646-3/2/1

Manufacturer FEI / 3006851654
Manufacturer Name / Wuxi Medicall lnstrument Factory
Manufacturer Address line 1 / No. 86 East Street, Zhangjing, Xibei
Manufacturer Address line 2 / Town, WuxiCity
Manufacturer's City / Jiangsu
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 62FAY23
Importer's Product Description / ALCOHOL PADS
Refusal Date / 27-Feb-2012
FDA District / FLA-DO
Entry/doc/line/sfx / TZ6-0116646-3/2/1
FDA Sample Analysis / Yes
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
NOT LISTED / 502(o), 801(a)(3); MISBRANDING / It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal TZ6-0117610-8/2/1

Manufacturer FEI / 3006851654
Manufacturer Name / Wuxi Medicall lnstrument Factory
Manufacturer Address line 1 / No. 86 East Street, Zhangjing, Xibei
Manufacturer Address line 2 / Town, WuxiCity
Manufacturer's City / Jiangsu
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 62FBY23
Importer's Product Description / ALCOHOL PADS
Refusal Date / 27-Feb-2012
FDA District / FLA-DO
Entry/doc/line/sfx / TZ6-0117610-8/2/1
FDA Sample Analysis / Yes
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
NOT LISTED / 502(o), 801(a)(3); MISBRANDING / It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal 820-4534093-0/1/1

Manufacturer FEI / 1000189256
Manufacturer Name / Yangzhou Pharmaceutical Co., Ltd
Manufacturer Address line 1 / 7 South Wenfeng Road
Manufacturer Address line 2
Manufacturer's City / Yangzhou, Jiangsu
Manufacturer Province/State / Ziangsu
Manufacturer Country/Area / China
Product Code / 64LAS37
Importer's Product Description / HYDROCORTISONE BASE MICRONIZED 100%FOR FURTHER MANUFACTURING OF OTC EX
Refusal Date / 17-Feb-2012
FDA District / NYK-DO
Entry/doc/line/sfx / 820-4534093-0/1/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
DIRECTIONS / 502(f)(1), 801(a)(3); MISBRANDING / The article appears to lack adequate directions for use.
NOT LISTED / 502(o), 801(a)(3); MISBRANDING / It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal 112-4899871-3/1/1

Manufacturer FEI / 3008888835
Manufacturer Name / Suzhou Tito Industry&Trade Co.Ltd
Manufacturer Address line 1 / Building D Integrated Boned Zone Ano.200
Manufacturer Address line 2
Manufacturer's City / Suzhousuzhou
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 79GEX
Importer's Product Description / 876732697581 MEDICAL LASER
Refusal Date / 28-Feb-2012
FDA District / SEA-DO
Entry/doc/line/sfx / 112-4899871-3/1/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
NO 510(K) / 801(a)(3); 502(o) Misbranding / It appears that a notice or other information respecting the device was not provided to FDA, as required by Section 510(k) and the device was not found to be substantially equivalent to a predicate device.
NO REGISTR / 536(a); Failure to file initial report / The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
NOT LISTED / 502(o), 801(a)(3); MISBRANDING / It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED / 502(o), 801(a)(3); MISBRANDING / It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(4).

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal UPS-4813879-2/1/1

Manufacturer FEI / 3009084642
Manufacturer Name / Millpledge Healthcare Supplies
Manufacturer Address line 1 / Building 4.3# Xuguan
Manufacturer Address line 2
Manufacturer's City / Suzhou
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 80KGX
Importer's Product Description / BURN DRESSING
Refusal Date / 01-Feb-2012
FDA District / NYK-DO
Entry/doc/line/sfx / UPS-4813879-2/1/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
REGISTERED / 502(o), 801(a)(3); MISBRANDING / It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(4).

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal T76-0200941-9/1/1

Manufacturer FEI / 3007140720
Manufacturer Name / Sterilance Medical (Suzhou) Inc.
Manufacturer Address line 1 / 68# Litanghe Rd
Manufacturer Address line 2
Manufacturer's City / Suzhou
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 80LKB
Importer's Product Description / ALCOHOL PREP PADS
Refusal Date / 01-Feb-2012
FDA District / DET-DO
Entry/doc/line/sfx / T76-0200941-9/1/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
NO 510(K) / 801(a)(3); 502(o) Misbranding / It appears that a notice or other information respecting the device was not provided to FDA, as required by Section 510(k) and the device was not found to be substantially equivalent to a predicate device.
NOT LISTED / 502(o), 801(a)(3); MISBRANDING / It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal FR1-0014247-5/1/1

Manufacturer FEI / 3006403682
Manufacturer Name / Jiangsu Province Jianerkang Medical Dressing Co.
Manufacturer Address line 1 / ZhiziTown
Manufacturer Address line 2
Manufacturer's City / Jintan City, Jiangsu
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 80LKB
Importer's Product Description / ALCOHOL PREP PADS FOR EXPORT ONLY
Refusal Date / 21-Feb-2012
FDA District / FLA-DO
Entry/doc/line/sfx / FR1-0014247-5/1/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
NOT LISTED / 502(o), 801(a)(3); MISBRANDING / It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal 112-2368476-7/4/1

Manufacturer FEI / 3005925379
Manufacturer Name / Ever Eyewear Co., Ltd
Manufacturer Address line 1 / P O Box 3018, Wenzhou
Manufacturer Address line 2
Manufacturer's City / Zhenjiang
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 86HQY
Importer's Product Description / 441835996649 SUNGLASSES
Refusal Date / 17-Feb-2012
FDA District / NOL-DO
Entry/doc/line/sfx / 112-2368476-7/4/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
NOT LISTED / 502(o), 801(a)(3); MISBRANDING / It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal 112-2311219-9/19/3

Manufacturer FEI / 3005925379
Manufacturer Name / Ever Eyewear Co., Ltd
Manufacturer Address line 1 / P O Box 3018, Wenzhou
Manufacturer Address line 2
Manufacturer's City / Zhenjiang
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 86HQY
Importer's Product Description / 441835995675 SUNGLASSES
Refusal Date / 17-Feb-2012
FDA District / NOL-DO
Entry/doc/line/sfx / 112-2311219-9/19/3
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
NOT LISTED / 502(o), 801(a)(3); MISBRANDING / It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal 112-2273962-0/14/1

Manufacturer FEI / 3005925379
Manufacturer Name / Ever Eyewear Co., Ltd
Manufacturer Address line 1 / P O Box 3018, Wenzhou
Manufacturer Address line 2
Manufacturer's City / Zhenjiang
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 86HQY
Importer's Product Description / 441835996329/SUNGLASSES
Refusal Date / 17-Feb-2012
FDA District / NOL-DO
Entry/doc/line/sfx / 112-2273962-0/14/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
NOT LISTED / 502(o), 801(a)(3); MISBRANDING / It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Import Refusal Report

FDA Home3

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal 112-2235084-0/11/1

Manufacturer FEI / 3005925379
Manufacturer Name / Ever Eyewear Co., Ltd
Manufacturer Address line 1 / P O Box 3018, Wenzhou
Manufacturer Address line 2
Manufacturer's City / Zhenjiang
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 86HQY
Importer's Product Description / 441835995701/SUNGLASSES
Refusal Date / 17-Feb-2012
FDA District / NOL-DO
Entry/doc/line/sfx / 112-2235084-0/11/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
NOT LISTED / 502(o), 801(a)(3); MISBRANDING / It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal 112-2209757-3/8/1

Manufacturer FEI / 3005925379
Manufacturer Name / Ever Eyewear Co., Ltd
Manufacturer Address line 1 / P O Box 3018, Wenzhou
Manufacturer Address line 2
Manufacturer's City / Zhenjiang
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 86HQY
Importer's Product Description / 441835995609/SUNGLASSES
Refusal Date / 17-Feb-2012
FDA District / NOL-DO
Entry/doc/line/sfx / 112-2209757-3/8/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
NOT LISTED / 502(o), 801(a)(3); MISBRANDING / It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal NS1-0008041-6/1/1

Manufacturer FEI / 3009398423
Manufacturer Name / Jane Ji
Manufacturer Address line 1 / No 168 Kaiyuan Rd Jiangningdistric
Manufacturer Address line 2
Manufacturer's City / Nanjing
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 90IZL
Importer's Product Description / X RAY MACHINE
Refusal Date / 17-Feb-2012
FDA District / FLA-DO
Entry/doc/line/sfx / NS1-0008041-6/1/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
NO 510(K) / 801(a)(3); 502(o) Misbranding / It appears that a notice or other information respecting the device was not provided to FDA, as required by Section 510(k) and the device was not found to be substantially equivalent to a predicate device.
NON STD / 536(a),(b); NON STANDARD / It appears that the article fails to comply with applicable standards prescribed under section 534.

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal MH9-0101013-1/1/1

Manufacturer FEI / 3005435248
Manufacturer Name / Huqiu Imaging Tech
Manufacturer Address line 1 / 388 Feng Jiang Road Mudu Industry
Manufacturer Address line 2
Manufacturer's City / Suzhou
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 90JAC
Importer's Product Description / X-RAY FILM PROCESSOR
Refusal Date / 29-Feb-2012
FDA District / FLA-DO
Entry/doc/line/sfx / MH9-0101013-1/1/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
NO REGISTR / 536(a); Failure to file initial report / The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
NOT LISTED / 502(o), 801(a)(3); MISBRANDING / It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Import Refusal Report

FDA Home3

Refusal Details as Recorded in OASIS by FDA

for Refusal AMG-0087273-3/2/1

Manufacturer FEI / 3004753388
Manufacturer Name / Chison Medical Imaging Co., Ltd.
Manufacturer Address line 1 / No. 8, Xiang Nan Road,
Manufacturer Address line 2 / Shuo Fang, New District
Manufacturer's City / Wuxi
Manufacturer Province/State
Manufacturer Country/Area / China
Product Code / 90MJS
Importer's Product Description / COMPLETE DIGITAL ULTRASOUND DIAGNOSIS SYSTEMS FOR EXPORT ONLY
Refusal Date / 16-Feb-2012
FDA District / FLA-DO
Entry/doc/line/sfx / AMG-0087273-3/2/1
FDA Sample Analysis / No
FDA Record of Private Lab Sample Analysis / No
Charge(s) / Violation Code / Section / Charge Statement
REGISTERED / 502(o), 801(a)(3); MISBRANDING / It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(4).
REGISTERED / 502(o), 801(a)(3); MISBRANDING / It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(4).

Import Refusal Report

FDA Home3