Elite Medical (Nanjing) Co., Ltd.
⚠️ Moderate Risk
FEI: 3009241290 • Nanjing, Jiangsu • CHINA
FEI Number
3009241290
Location
Nanjing, Jiangsu
Country
CHINAAddress
Ying Jiang Yuan 62 Room 909, , Nanjing, 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
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).
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).
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 |
|---|---|---|---|
| 12/5/2014 | 77NLBTROCAR, TRACHEAL, LARYNGEAL, SINUS, REPROCESSED | New Orleans District Office (NOL-DO) | |
| 4/6/2012 | 79HAZSPONGE FOR INTERNAL USE | Division of Southeast Imports (DSEI) | |
| 3/22/2012 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | Division of Southeast Imports (DSEI) | |
| 3/22/2012 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | Division of Southeast Imports (DSEI) | |
| 3/22/2012 | 79GESBLADE, SCALPEL | Division of Southeast Imports (DSEI) | |
| 3/22/2012 | 73OGGHUMIDIFIER NEBULIZER KIT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Elite Medical (Nanjing) Co., Ltd.'s FDA import refusal history?
Elite Medical (Nanjing) Co., Ltd. (FEI: 3009241290) has 6 FDA import refusal record(s) in our database, spanning from 3/22/2012 to 12/5/2014.
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. Elite Medical (Nanjing) Co., Ltd.'s FEI number is 3009241290.
What types of violations has Elite Medical (Nanjing) Co., Ltd. received?
Elite Medical (Nanjing) Co., Ltd. has been cited for 3 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 Elite Medical (Nanjing) Co., Ltd. come from?
All FDA import refusal data for Elite Medical (Nanjing) 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.