Shanghai Lord International Trade Co., Ltd.
⚠️ Moderate Risk
FEI: 3005133210 • Shanghai • CHINA
FEI Number
3005133210
Location
Shanghai
Country
CHINAAddress
Rm. C, Floor 22, Zhi Yuan Bldg.,, No. 768 Xie Tu Road, 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
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 11/13/2009 | 80LDQDEVICE, GENERAL MEDICAL | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 11/13/2009 | 80LDQDEVICE, GENERAL MEDICAL | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 8/28/2009 | 74DXQCUFF, BLOOD-PRESSURE | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 8/28/2009 | 74DXQCUFF, BLOOD-PRESSURE | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 8/21/2009 | 74DXQCUFF, BLOOD-PRESSURE | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 8/21/2009 | 74DXQCUFF, BLOOD-PRESSURE | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 7/8/2009 | 74DXQCUFF, BLOOD-PRESSURE | 290DE IMP GMP | New York District Office (NYK-DO) |
| 12/9/2008 | 74DXQCUFF, BLOOD-PRESSURE | Southwest Import District Office (SWI-DO) | |
| 8/6/2007 | 74LDESTETHOSCOPE, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/6/2007 | 74LDESTETHOSCOPE, MANUAL | 16DIRECTIONS | Florida District Office (FLA-DO) |
| 9/2/2005 | 80LDQDEVICE, GENERAL MEDICAL | Southwest Import District Office (SWI-DO) | |
| 9/2/2005 | 80LDQDEVICE, GENERAL MEDICAL | Southwest Import District Office (SWI-DO) | |
| 8/26/2005 | 80LDQDEVICE, GENERAL MEDICAL | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Shanghai Lord International Trade Co., Ltd.'s FDA import refusal history?
Shanghai Lord International Trade Co., Ltd. (FEI: 3005133210) has 13 FDA import refusal record(s) in our database, spanning from 8/26/2005 to 11/13/2009.
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 Lord International Trade Co., Ltd.'s FEI number is 3005133210.
What types of violations has Shanghai Lord International Trade Co., Ltd. received?
Shanghai Lord International Trade Co., Ltd. has been cited for 7 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 Lord International Trade Co., Ltd. come from?
All FDA import refusal data for Shanghai Lord International Trade 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.