Roosin Medical Co., Ltd.
⚠️ Moderate Risk
FEI: 3007124979 • Taizhou, Jiangsu • CHINA
FEI Number
3007124979
Location
Taizhou, Jiangsu
Country
CHINAAddress
Gaogang Shangcheng, Kouanzhen Gaogang District, Taizhou, Jiangsu, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
STERILITY
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/20/2023 | 79FRODRESSING, WOUND, DRUG | Division of Southeast Imports (DSEI) | |
| 4/25/2017 | 79NAEDRESSING, WOUND, HYDROGEL | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 4/5/2017 | 79NAEDRESSING, WOUND, HYDROGEL | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 11/2/2015 | 79NACDRESSING, WOUND, HYDROPHILIC | Baltimore District Office (BLT-DO) | |
| 2/25/2015 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Roosin Medical Co., Ltd.'s FDA import refusal history?
Roosin Medical Co., Ltd. (FEI: 3007124979) has 5 FDA import refusal record(s) in our database, spanning from 2/25/2015 to 7/20/2023.
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. Roosin Medical Co., Ltd.'s FEI number is 3007124979.
What types of violations has Roosin Medical Co., Ltd. received?
Roosin Medical Co., Ltd. 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 Roosin Medical Co., Ltd. come from?
All FDA import refusal data for Roosin Medical 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.