Shanghai Jiu He Import And Export Co.

⚠️ High Risk

FEI: 3003379018 • Shanghai • CHINA

FEI

FEI Number

3003379018

📍

Location

Shanghai

🇨🇳

Country

CHINA

🏢

Address

433 Zhao Jia Bang Road, , Shanghai, , China

High Risk

FDA Import Risk Assessment

53.6

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

189

Total Refusals

Unique Violations

9/7/2005

Latest Refusal

8/5/2002

Earliest Refusal

Score Breakdown

Violation Severity

45.7×40%

Refusal Volume

84.4×30%

Recency

0.0×20%

Frequency

100.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

341166×

REGISTERED

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)(5).

11885×

NOT LISTED

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).

50853×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

23714×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

238014×

NO PMA/PDP

The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).

Refusal History

Date	Product	Violations	Division
9/7/2005	80FLLTHERMOMETER, ELECTRONIC, CLINICAL	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	79GESBLADE, SCALPEL	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80FMADEPRESSOR, TONGUE	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80JOLCATHETER AND TIP, SUCTION	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	74DXQCUFF, BLOOD-PRESSURE	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	85HEDDOUCHE APPARATUS, VAGINAL, THERAPEUTIC	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80GAZTUBING, NONINVASIVE	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	88KEWSLIDES, MICROSCOPE	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80MRZACCESSORIES, PUMP, INFUSION	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	79GEMGAUZE, ABSORBABLE	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80FMHCONTAINER, SPECIMEN	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	73BSKCUFF, TRACHEAL TUBE, INFLATABLE	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	85HDZKNIFE, CERVICAL CONE	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80MRZACCESSORIES, PUMP, INFUSION	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80LRTINDICATOR, STERILIZATION	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	80FPASET, ADMINISTRATION, INTRAVASCULAR	341REGISTERED	Florida District Office (FLA-DO)
9/7/2005	76EFNCOTTON, ROLL	341REGISTERED	Florida District Office (FLA-DO)
6/9/2005	80FLLTHERMOMETER, ELECTRONIC, CLINICAL	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/9/2005	79GESBLADE, SCALPEL	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/9/2005	74DXQCUFF, BLOOD-PRESSURE	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/9/2005	85HDFSPECULUM, VAGINAL, METAL	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/9/2005	77KCPSYRINGE, ENT	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/9/2005	80FPBFILTER, INFUSION LINE	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/9/2005	80FPFBOTTLE, HOT/COLD WATER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/9/2005	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/9/2005	78FPDTUBE, FEEDING	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/9/2005	79FXXMASK, SURGICAL	341REGISTERED	Division of Southeast Imports (DSEI)
6/9/2005	79GEMGAUZE, ABSORBABLE	341REGISTERED	Division of Southeast Imports (DSEI)
6/9/2005	80KZDINFUSOR, PRESSURE, FOR I.V. BAGS	341REGISTERED	Division of Southeast Imports (DSEI)
4/11/2005	85HDFSPECULUM, VAGINAL, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/11/2005	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/11/2005	80MRZACCESSORIES, PUMP, INFUSION	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/11/2005	78FPDTUBE, FEEDING	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/11/2005	73LNZCHANGER, TUBE, ENDOTRACHEAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/11/2005	80FMADEPRESSOR, TONGUE	341REGISTERED	Florida District Office (FLA-DO)
4/11/2005	78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	341REGISTERED	Florida District Office (FLA-DO)
4/11/2005	77KBLDEPRESSOR, METAL TONGUE, ENT	341REGISTERED	Florida District Office (FLA-DO)
4/11/2005	80FLLTHERMOMETER, ELECTRONIC, CLINICAL	341REGISTERED	Florida District Office (FLA-DO)
4/11/2005	80FMEGOWN, EXAMINATION	341REGISTERED	Florida District Office (FLA-DO)
4/11/2005	79GESBLADE, SCALPEL	341REGISTERED	Florida District Office (FLA-DO)
4/11/2005	88KEWSLIDES, MICROSCOPE	341REGISTERED	Florida District Office (FLA-DO)
4/11/2005	79GEMGAUZE, ABSORBABLE	341REGISTERED	Florida District Office (FLA-DO)
4/11/2005	78EYJHOLDER, URETERAL CATHETER	341REGISTERED	Florida District Office (FLA-DO)
4/11/2005	77KCPSYRINGE, ENT	341REGISTERED	Florida District Office (FLA-DO)
4/11/2005	85HHTSPATULA, CERVICAL, CYTOLOGICAL	341REGISTERED	Florida District Office (FLA-DO)
4/11/2005	80LRTINDICATOR, STERILIZATION	341REGISTERED	Florida District Office (FLA-DO)
4/11/2005	76EFNCOTTON, ROLL	341REGISTERED	Florida District Office (FLA-DO)
11/29/2004	73KGBMASK, OXYGEN, NON-REBREATHING	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	80FMADEPRESSOR, TONGUE	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	80JOLCATHETER AND TIP, SUCTION	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	80GAZTUBING, NONINVASIVE	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	85HGYPUMP, BREAST, NON-POWERED	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	77KBLDEPRESSOR, METAL TONGUE, ENT	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	80FLLTHERMOMETER, ELECTRONIC, CLINICAL	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	79GESBLADE, SCALPEL	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	74LDESTETHOSCOPE, MANUAL	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	74DXQCUFF, BLOOD-PRESSURE	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	80FMEGOWN, EXAMINATION	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	77KCPSYRINGE, ENT	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	88KEWSLIDES, MICROSCOPE	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	80FPFBOTTLE, HOT/COLD WATER	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	78FPDTUBE, FEEDING	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	80FMHCONTAINER, SPECIMEN	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	73KGBMASK, OXYGEN, NON-REBREATHING	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	85HDZKNIFE, CERVICAL CONE	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	80LRTINDICATOR, STERILIZATION	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/29/2004	76EFNCOTTON, ROLL	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
10/27/2004	78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	80FMADEPRESSOR, TONGUE	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	80FLLTHERMOMETER, ELECTRONIC, CLINICAL	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	79GESBLADE, SCALPEL	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	74LDESTETHOSCOPE, MANUAL	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	74DXQCUFF, BLOOD-PRESSURE	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	85HEDDOUCHE APPARATUS, VAGINAL, THERAPEUTIC	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	85HDZKNIFE, CERVICAL CONE	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	77KCPSYRINGE, ENT	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	79FXXMASK, SURGICAL	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	79HTEELEVATOR	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	85HDZKNIFE, CERVICAL CONE	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/27/2004	79GEMGAUZE, ABSORBABLE	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
9/10/2004	80FORAPPLICATOR, ABSORBENT TIPPED	118NOT LISTED	Florida District Office (FLA-DO)
9/10/2004	76EFNCOTTON, ROLL	118NOT LISTED	Florida District Office (FLA-DO)
9/10/2004	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	118NOT LISTED	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Shanghai Jiu He Import And Export Co.'s FDA import refusal history?

Shanghai Jiu He Import And Export Co. (FEI: 3003379018) has 189 FDA import refusal record(s) in our database, spanning from 8/5/2002 to 9/7/2005.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Shanghai Jiu He Import And Export Co.'s FEI number is 3003379018.

What types of violations has Shanghai Jiu He Import And Export Co. received?

Shanghai Jiu He Import And Export Co. has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Shanghai Jiu He Import And Export Co. come from?

All FDA import refusal data for Shanghai Jiu He Import And Export Co. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.