Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd
⚠️ Moderate Risk
FEI: 3003995556 • Hangzhou, Zhejiang • CHINA
FEI Number
3003995556
Location
Hangzhou, Zhejiang
Country
CHINAAddress
866 Moganshanlu, , 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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2016 | 56YXS99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/17/2015 | 62GAY89CYCLOSPORINE (ANTI-INFLAMMATORY) | New Orleans District Office (NOL-DO) | |
| 11/12/2013 | 61GCT81MUPIROCIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/12/2013 | 61GCT81MUPIROCIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 56FDS30POLYMYXIN B SULFATE (PEPTIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/19/2011 | 61GCS81MUPIROCIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
| 10/11/2011 | 61FCA56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | Seattle District Office (SEA-DO) | |
| 8/4/2011 | 61GCS81MUPIROCIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | Los Angeles District Office (LOS-DO) | |
| 8/4/2011 | 61GCS81MUPIROCIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd's FDA import refusal history?
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd (FEI: 3003995556) has 9 FDA import refusal record(s) in our database, spanning from 8/4/2011 to 3/16/2016.
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. Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd's FEI number is 3003995556.
What types of violations has Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd received?
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd has been cited for 4 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 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd come from?
All FDA import refusal data for Hangzhou Zhongmei Huadong Pharmaceutical 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.