Zhengrui Pharma & Chemical Co Lt
⚠️ Moderate Risk
FEI: 3008902837 • Taizhou • CHINA
FEI Number
3008902837
Location
Taizhou
Country
CHINAAddress
Chuanxin Industrial Park Xianju, , Taizhou, , 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
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 in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/12/2011 | 63XIZ83MANNITOL (DIAGNOSTIC AID) (DRUGS) | New Orleans District Office (NOL-DO) | |
| 9/27/2011 | 63XIZ83MANNITOL (DIAGNOSTIC AID) (DRUGS) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Zhengrui Pharma & Chemical Co Lt's FDA import refusal history?
Zhengrui Pharma & Chemical Co Lt (FEI: 3008902837) has 2 FDA import refusal record(s) in our database, spanning from 9/27/2011 to 12/12/2011.
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. Zhengrui Pharma & Chemical Co Lt's FEI number is 3008902837.
What types of violations has Zhengrui Pharma & Chemical Co Lt received?
Zhengrui Pharma & Chemical Co Lt 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 Zhengrui Pharma & Chemical Co Lt come from?
All FDA import refusal data for Zhengrui Pharma & Chemical Co Lt 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.