SHANGHAI MEDICINES & HEALTH PRODUCTS IMP. & EXP.
⚠️ Moderate Risk
FEI: 3008729549 • Shanghai, Shanghai • CHINA
FEI Number
3008729549
Location
Shanghai, Shanghai
Country
CHINAAddress
158 Han Zhong Road, , 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
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).
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).
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).
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.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2022 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/7/2022 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/17/2013 | 56BYR13DISODIUM CARBENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Los Angeles District Office (LOS-DO) | |
| 4/2/2013 | 61CIA01LEUCOVORIN CALCIUM (ANTI-ANEMIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/2/2013 | 61CIA01LEUCOVORIN CALCIUM (ANTI-ANEMIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/20/2012 | 54FMR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 238UNSAFE ADD | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is SHANGHAI MEDICINES & HEALTH PRODUCTS IMP. & EXP.'s FDA import refusal history?
SHANGHAI MEDICINES & HEALTH PRODUCTS IMP. & EXP. (FEI: 3008729549) has 6 FDA import refusal record(s) in our database, spanning from 7/20/2012 to 1/7/2022.
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 IMP. & EXP.'s FEI number is 3008729549.
What types of violations has SHANGHAI MEDICINES & HEALTH PRODUCTS IMP. & EXP. received?
SHANGHAI MEDICINES & HEALTH PRODUCTS IMP. & EXP. 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 SHANGHAI MEDICINES & HEALTH PRODUCTS IMP. & EXP. come from?
All FDA import refusal data for SHANGHAI MEDICINES & HEALTH PRODUCTS IMP. & EXP. 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.