A.R Medicom Inc (Shanghai) Ltd.
⚠️ Moderate Risk
FEI: 3006691703 • Shanghai, Shanghai • CHINA
FEI Number
3006691703
Location
Shanghai, Shanghai
Country
CHINAAddress
290 Xiangche Rd,, , Songjiang, Shanghai, Shanghai, 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
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.
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).
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/27/2014 | 76EFNCOTTON, ROLL | Division of Northeast Imports (DNEI) | |
| 8/27/2014 | 76EFNCOTTON, ROLL | Division of Northeast Imports (DNEI) | |
| 8/27/2014 | 76EFNCOTTON, ROLL | Division of Northeast Imports (DNEI) | |
| 8/27/2014 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | Division of Northeast Imports (DNEI) |
| 6/27/2014 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | San Francisco District Office (SAN-DO) |
| 6/27/2014 | 76EFNCOTTON, ROLL | 78STERILITY | San Francisco District Office (SAN-DO) |
| 6/9/2014 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | Los Angeles District Office (LOS-DO) | |
| 6/9/2014 | 76EFNCOTTON, ROLL | Los Angeles District Office (LOS-DO) | |
| 11/9/2010 | 79FXXMASK, SURGICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/9/2010 | 79FXXMASK, SURGICAL | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is A.R Medicom Inc (Shanghai) Ltd.'s FDA import refusal history?
A.R Medicom Inc (Shanghai) Ltd. (FEI: 3006691703) has 10 FDA import refusal record(s) in our database, spanning from 11/9/2010 to 8/27/2014.
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. A.R Medicom Inc (Shanghai) Ltd.'s FEI number is 3006691703.
What types of violations has A.R Medicom Inc (Shanghai) Ltd. received?
A.R Medicom Inc (Shanghai) 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 A.R Medicom Inc (Shanghai) Ltd. come from?
All FDA import refusal data for A.R Medicom Inc (Shanghai) 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.