SHANGHAI MEDICINES & HEALTH PRODUCTS I/E CORP.
⚠️ Moderate Risk
FEI: 2000021163 • Shanghai, Cn-31 • CHINA
FEI Number
2000021163
Location
Shanghai, Cn-31
Country
CHINAAddress
27 ZHONGSHAN ROAD (E.1), , Shanghai, Cn-31, 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
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).
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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/2/2007 | 76EGSHANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/2/2007 | 76EGSHANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 9/24/2007 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2920PESTICIDES | Los Angeles District Office (LOS-DO) |
| 6/26/2006 | 89NHNLAMP, NON-HEATING, FOR ADJUNCTIVE USE IN PAIN THERAPY | Los Angeles District Office (LOS-DO) | |
| 3/4/2004 | 25PGH99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C. | 249FILTHY | Seattle District Office (SEA-DO) |
| 1/8/2004 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/29/2002 | 79JCYCATHETER, INFUSION | Florida District Office (FLA-DO) | |
| 1/28/2002 | 79JCYCATHETER, INFUSION | Florida District Office (FLA-DO) | |
| 1/28/2002 | 79JCYCATHETER, INFUSION | Florida District Office (FLA-DO) | |
| 10/18/2001 | 79JCYCATHETER, INFUSION | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is SHANGHAI MEDICINES & HEALTH PRODUCTS I/E CORP.'s FDA import refusal history?
SHANGHAI MEDICINES & HEALTH PRODUCTS I/E CORP. (FEI: 2000021163) has 10 FDA import refusal record(s) in our database, spanning from 10/18/2001 to 10/2/2007.
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 MEDICINES & HEALTH PRODUCTS I/E CORP.'s FEI number is 2000021163.
What types of violations has SHANGHAI MEDICINES & HEALTH PRODUCTS I/E CORP. received?
SHANGHAI MEDICINES & HEALTH PRODUCTS I/E CORP. 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 SHANGHAI MEDICINES & HEALTH PRODUCTS I/E CORP. come from?
All FDA import refusal data for SHANGHAI MEDICINES & HEALTH PRODUCTS I/E CORP. 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.