Zhejiang Medicines & Health Products Import & Export Co. Ltd
⚠️ Moderate Risk
FEI: 3004265295 • Hangzhou, Zhejiang • CHINA
FEI Number
3004265295
Location
Hangzhou, Zhejiang
Country
CHINAAddress
21 Chuxin Road, , Hangzhou, Zhejiang, 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).
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).
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
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.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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.
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 |
|---|---|---|---|
| 9/3/2014 | 65FAH03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID) | New Orleans District Office (NOL-DO) | |
| 9/3/2014 | 66VAC99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 9/3/2014 | 60LAC99ANALGESIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 9/3/2014 | 62LAB40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New Orleans District Office (NOL-DO) | |
| 9/3/2014 | 56ECF20DOXYCYCLINE (TETRACYCLINES) | New Orleans District Office (NOL-DO) | |
| 9/3/2014 | 66VAC99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 9/3/2014 | 56AAC99PENICILLIN NATURAL, N.E.C. | New Orleans District Office (NOL-DO) | |
| 9/3/2014 | 66VAC99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 9/3/2014 | 66VAC99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 9/3/2014 | 60LAA05ASPIRIN (ANALGESIC) | New Orleans District Office (NOL-DO) | |
| 8/29/2013 | 61JCR12LOVASTATIN (ANTI-CHOLESTEREMIC) | 3500RXLABEL | Division of Northeast Imports (DNEI) |
| 12/7/2012 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northeast Imports (DNEI) | |
| 4/26/2012 | 56HIS24DOXORUBICIN HYDROCHLORIDE (ANTITUMOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/28/2011 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 249FILTHY | New York District Office (NYK-DO) |
| 10/27/2011 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 9/28/2009 | 62RQS11PRAZIQUANTEL (ANTI-SCHISTOSOMAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/24/2008 | 54FBZ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 251POISONOUS | Southwest Import District Office (SWI-DO) |
| 1/24/2008 | 54FBZ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 251POISONOUS | Southwest Import District Office (SWI-DO) |
| 1/23/2008 | 54FBW99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 251POISONOUS | Southwest Import District Office (SWI-DO) |
| 7/9/2007 | 54CBW05L-CYSTEINE (PROTEIN) | 238UNSAFE ADD | Southwest Import District Office (SWI-DO) |
| 7/19/2006 | 54FAW48GINKGO BILOBA (HERBAL & BOTANICALS, NOT TEAS) | 320LACKS FIRM | Los Angeles District Office (LOS-DO) |
| 10/3/2005 | 54FAR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 10/3/2005 | 54FAR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 8/7/2002 | 79KDCINSTRUMENT, SURGICAL, DISPOSABLE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/25/2001 | 54GBR04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS) | 249FILTHY | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Zhejiang Medicines & Health Products Import & Export Co. Ltd's FDA import refusal history?
Zhejiang Medicines & Health Products Import & Export Co. Ltd (FEI: 3004265295) has 25 FDA import refusal record(s) in our database, spanning from 10/25/2001 to 9/3/2014.
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. Zhejiang Medicines & Health Products Import & Export Co. Ltd's FEI number is 3004265295.
What types of violations has Zhejiang Medicines & Health Products Import & Export Co. Ltd received?
Zhejiang Medicines & Health Products Import & Export Co. Ltd has been cited for 10 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 Zhejiang Medicines & Health Products Import & Export Co. Ltd come from?
All FDA import refusal data for Zhejiang Medicines & Health Products Import & Export 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.