Yangzhou Super-Union Medical Material Co., Ltd.
⚠️ High Risk
FEI: 3004635134 • YIZHENG, Jiangsu • CHINA
FEI Number
3004635134
Location
YIZHENG, Jiangsu
Country
CHINAAddress
118 SOUTH XISHAN ROAD, CHENJI TOWN, YIZHENG, Jiangsu, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
© ImportRefusal.com Original Analysis
Violation Summary
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/16/2022 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | Division of Northern Border Imports (DNBI) |
| 7/19/2021 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | Division of Southwest Imports (DSWI) |
| 10/10/2019 | 79LRRKIT, FIRST AID | Division of Northern Border Imports (DNBI) | |
| 9/26/2019 | 79LRRKIT, FIRST AID | Division of Northern Border Imports (DNBI) | |
| 5/1/2019 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | Division of Southwest Imports (DSWI) |
| 1/29/2019 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | Division of Southwest Imports (DSWI) | |
| 12/7/2018 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 2800POSS N/STR | Division of Southeast Imports (DSEI) |
| 12/7/2018 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 2800POSS N/STR | Division of Southeast Imports (DSEI) |
| 12/6/2018 | 79OHOFIRST AID KIT WITHOUT DRUG | 78STERILITY | Division of Southeast Imports (DSEI) |
| 7/18/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | 78STERILITY | Division of West Coast Imports (DWCI) |
| 5/11/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Yangzhou Super-Union Medical Material Co., Ltd.'s FDA import refusal history?
Yangzhou Super-Union Medical Material Co., Ltd. (FEI: 3004635134) has 11 FDA import refusal record(s) in our database, spanning from 5/11/2017 to 8/16/2022.
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. Yangzhou Super-Union Medical Material Co., Ltd.'s FEI number is 3004635134.
What types of violations has Yangzhou Super-Union Medical Material Co., Ltd. received?
Yangzhou Super-Union Medical Material Co., Ltd. has been cited for 6 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 Yangzhou Super-Union Medical Material Co., Ltd. come from?
All FDA import refusal data for Yangzhou Super-Union Medical Material Co., Ltd. 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.